Olympus urology fda pdf

Olympus has developed an nbi urology app for physicians. In addition, olympus is pleased to extend its olympus advantage program to the urology market. This advisory committee meeting is a follow up to the gastroenterology and urology devices. The urfv2 features a micromini ccd which enables the outer diameter to be significantly smaller than previousgeneration flexible video ureteroscope 1. Our complete line of highquality bipolar electrodes are fda validated for use on olympus, storz and. The new visera elite ii surgical endoscope system features infrared ir imaging, a subject.

Olympus s commitment to urology is an ongoing pursuit of innovation, constantly aiming to further improve levels of patient care. Cystoscopy is one of the most commonly performed procedures in the urology office setting, and is an. Tur urology products olympus medical systems india. Dec 15, 2014 olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today fda 510k clearance of.

Olympus to distribute terumo glidewire, urologic hydrophilic. Urology gynaecology general surgery endoeye flex hd 10 mm is a multichip, flexible video laparoscope with a 10 mm distal diameter and provides excellent hd image quality. The uropass access sheath full portfolio, which has devices that enable multiple. Equivalent to olympus wa22503dwa22603d 12 medium loop lpo12qfm equivalent to olympus wa22302dwa22602d 30 medium loop lpo30qfm equivalent to olympus wa22306d wa22606d 30 supernoma loop lpo30qfl equivalent to olympus wa22507d wa22607d hemielectrode hemioqf equivalent to olympus wa22557c wa22657c wa22566s. Through gamechanging technologies and highend products, we are pioneering and redefining trends and market standards. Thunderbeat hybrid energy urology olympus medical systems. Olympus 510k summary evis exera 11 180 system may 2 0 2008 1. Olympus offers the optimised solution for outpatient departments. Lithovue a new scope for every patient boston scientific us. Urology the oes pro range of singlechannel ureteroscopes is ideal for all aspects of semirigid ureteroscopy urs. Olympus launches five new urology devices, expanding complete. Sterilant refers to a chemical germicide that has been cleared by the fda as capable of destroying all microorganisms, including all bacterial spores rutala et al. Listing a study does not mean it has been evaluated by the u.

The glidewire urologic guidewire is considered the gold standard of guidewire offerings, and is an excellent complement to the imaging and therapeutic device solutions of the olympus urology segment. Olympus introduces five new urology products 20150518. Food and drug administration 9200 corporate boulevard rockville md 20850 may 2 0 2008. Cystoscopy urology products olympus medical singapore.

Enter the product reference number ref, which is located on the label of your olympus medical product into the search field and press search. Gyrusacmiolympus invisiodurd twelve month failure and repair experience. Urology gynecology business unit ugbu urology field gynecology field flexible and rigid endoscopes ureteroscopes and cystoscopes stone treatment devices disposable flexible hysteroscopes resectoscopes colposcopes the figure for surgical devices net sales. Lisinoprilhydrochlorothiazide prinzide, zestoretic 3. Explore the benefits and products for general surgery, urology and gynecology. The outpatient imaging platform cv170 allows costeffective access to the power of hd and nbi in endoscopic diagnosis in urology.

Olympus is the solution provider for all relevant products used for endoscope reprocessing. Olympus has a track record of developing and supplying products for endoscopic surgery in its role as a vendor of all forms of endoscopy. System guide endoscopy olympus surgical technologies europe. You can also improve the search results by setting the filters medical specialty andor language. Thunderbeat is the worlds first and only advanced energy system that delivers two. The new design provides unsurpassed detail and color reproduction while minimizing operator fatigue. Olympus launches five new urology devices, expanding. Olympus receives fda clearance for narrow band imaging. Our new surgical imaging platform, visera elite, is equipped with hd imaging capability and advanced image processing to provide the best possible image for. Corp 510k status letter august 12, 2015 pdf 449kb olympus 510k. Beginning immediately, the olympus urology and stone management sales force will distribute the device to u. Jun 08, 2016 the olympus study optimized delivery of mitomycin for primary utuc study olympus the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

The commitment by olympus to urology is an ongoing pursuit of innovation, constantly aiming to further improve the level of patient care. Olympus narrow band imaging for cystoscopy cleared by fda december 30th, 2014 medgadget editors urology olympus received clearance from the fda to introduce its narrow band imaging technology in. Urology and pelvic health product catalog and ordering information visualization products guidewires. This is the only endoscopic light imaging system that helps resolve lesions without dyes or. Having a long history in supporting physicians needs in stone management through the provision of rigid and flexible ureteroscopes and the related video equipment, olympus is well aware of the additional procedural requirements resulting from the use of singleuse instruments as well as holmium lasers and lithotriptors.

Fda worked closely with fujifilm, olympus, and pentax as they evaluated the sealing. Lithotripsy systems urology olympus medical systems. Food and drug administration 9200 corporate boulevard rockville md 20850 olympus medical systems corp. Olympus narrow band imaging for cystoscopy cleared by fda. Pss quickfire bipolar electrodes cut costs and reduce procedure times, guaranteed. The range includes straight channel with angled ocular or angled channel with straight ocular, both with 7o direction of view and 4. Olympus offers the optimized solution for outpatient departments. Sterile refers to the state of being free from viable microorganisms aami, 2010. Table of contents urology times issn 00939722 print, issn 21507384 digital is published 12 times a year by multimedia healthcare llc, 230 w superior st, ste 400, duluth mn 55802. Yag lasers empowers physicians and hospital systems to meet the diverse surgical challenges they face each day. This includes products for manual precleaning brushes and adapters, the olympus washerdisinfector family, and dedicated products for endoscope drying, storage, and.

Terumo announced on monday that it finalized a basic agreement with fellow japanese devicemaker olympus to expand their u. Dec 05, 2014 olympus has received fdaclearance for the screening and surveillance of barretts esophagus and is currently exploring other claims for nbi both in gynecology and general surgery. Olympus has developed an nbi urology app for physicians, available in the app store with the olympus nbi search terms. Launch of visera elite ii surgical endoscope system. Highresolution hdtv images deliver sharp and clear details, improving observation capabilities when examining mucosal structures and additional. Fda clears olympus narrow band imaging nbi for effective. Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today fda. Thunderbeat is the worlds first and only advanced energy system that delivers two wellestablished forms of energy to a tissue simultaneously. The deal stipulates both companies will jointly market urology products in the u. Multisociety guideline on reprocessing flexible gastrointestinal.

Drug list by therapeutic category cardiovascular drugs 01. Urology pulmonology gynaecology general surgery ear, nose, throat gastroenterology. New olympus a3551, a3560, a3550 urological instrument for. Gastroenterology urology olympus medical systems corp.

Olympus meets the needs of our urology customers with a family of urology instruments for diagnostic and therapeutic procedures in hospitals, ambulatory surgery centers, and offices. The olympus advantage program is designed to reduce the overall cost of olympus capital products such. Compatible for use with olympus brand oes pro series resectoscope compatible for use with wolf brand eline series. With gamechanging technologies and highend products, we are pioneering and redefining trends and market standards. This year, olympus celebrates 100 years of making peoples lives healthier, safer and more fulfilling around the world.

Pss quickfire bipolar electrodes were developed based on feedback from customers. Edits made to the original white paper in 2014 are noted in italics. Infections associated with reprocessed duodenoscopes fda. Oes pro continuous flow lasercystoscope unique laser control adapter. The portfolio is designed to suit adolescents as well as more difficult anatomies. With the 4k technology, olympus is now striving to make endoscopic visibility even better than open surgery by adding features such as ultra high definition, wider color gamut, and magnified visualization. For any other country, visit our companys global website at. Olympus endoscopy surgical instruments endoscopy superstore. Occupational safety and health administration osha, 2012. Olympus has received fda clearance for the screening and surveillance of barretts esophagus and is currently exploring other claims for nbi both in gynecology and general surgery. Cystoscopy urology products olympus medical systems vietnam.

Experience the olympus empower h35 laser for lithotripsy and the olympus empower h65 h100 system that offer additional capabilities for soft tissue and bph treatment. Prospective randomized trial comparing 2 flexible digital ureteroscopes. Pss quickfire bipolar electrodes pss urology pss urology. Pediatric cystoscope pediatric urology olympus medical. As a complete urology provider we are active in bph, nmibc, stone management and. Olympus received clearance from the fda to introduce its narrow band imaging technology in the u. To make sure that you use the most recent version of the system guide endoscopy, check our website.

Olympus aims to provide innovative energy solutions delivering surgical safety and instrument versatility for efficient and streamlined operations with optimal patient outcomes. Fda 510k applications submitted by olympus america, inc. Olympus has received fda clearance for the screening and surveillance of barretts esophagus and is currently exploring other claims for. The olympus study optimized delivery of mitomycin for primary utuc study olympus the safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Olympus compact cystoscope is ideal for paediatric surgery due to its slim design. This page contains information about infections associated with reprocessed duodenoscopes. The olympus study optimized delivery of mitomycin for. Food and drug administration 9200 corporate boulevard rockville md. In line with all olympus cystoscopes, this compact version still has all the ergonomics and quality that you would. Quentin clemens, md, msci, chair robert dowling, md frances foley, ms, rn, curn howard goldman, md chris gonzalez, md.