FDA 510(k)

HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L

K-Number: K090980 · 2009-06-29

Decision Date2009-06-29

Product CodeNWB

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Winter & Ibe GmbH. It received FDA 510(k) clearance on 2009-06-29 under 510(k) number K090980. The device is classified under product code NWB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L?

HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L is a medical device that received FDA 510(k) clearance on 2009-06-29. The listed applicant is Olympus Winter & Ibe GmbH. The 510(k) number is K090980.

When did HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L receive FDA 510(k) clearance?

HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L received FDA 510(k) clearance on 2009-06-29, under 510(k) number K090980.

Who is the listed applicant for HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L?

The FDA 510(k) record lists Olympus Winter & Ibe GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L?

The FDA product code for HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L is NWB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Olympus Winter & Ibe GmbH as applicant

K260649OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 19.8 Fr. (WA2C19BO); Obturator, 21 Fr. (WA2C21BO); Obturator, 21 Fr., for sheath with ramp (WA2C21RO); Obturator, 21 Fr., long (WA2C21LO); Obturator, 21 Fr., for straight sheath (WA2C21SO); Obturator, 22.5 Fr. (WA2C22BO); Obturator, 25 Fr. (WA2C25BO); Obturator, optical, 19.8 Fr. (WA2C19BV); Obturator, optical, 21 Fr. (WA2C21BV); Obturator, optical, 21 Fr., for straight sheath (WA2C21SV); Obturator, optical,K252043Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep plus (WB990311); Bipolar applicator CelonProBreath (WB990210); Bipolar applicator CelonProSleep plus (WB990211)K231777Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)K221522HF-cables (resusable)K223183Light-Guide Cables K213207Sheath, Stopcock Accessory

View all 36 devices →

Related Devices (Code: NWB)

K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.K211882HD-550 Video Endoscope SystemSonoscape Medical Corp.K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.K100584EVIS EXERAII 180 SYSTEMOlympus Medical Systems Corporation K072957EVIS EXERA II 180 SYSTEMOlympus Medical Systems Corporation K062049EVIS EXERA II 180 SYSTEMOlympus Medical Systems Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.