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510(k) K090980

HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L by Olympus Winter & Ibe GmbH — Product Code NWB

K090980 is an FDA 510(k) premarket notification submitted by Olympus Winter & Ibe GmbH for the device "HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L". The FDA issued a decision of Substantially Equivalent on June 29, 2009. The device falls under product code NWB (Endoscope, Accessories, Narrow Band Spectrum), a Class II device regulated under 21 CFR 876.1500. Olympus Winter & Ibe GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2009
Date Received
April 7, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Accessories, Narrow Band Spectrum
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.

Other clearances by Olympus Winter & Ibe GmbH

  • K260649 — OES ELITE Cystoscope and Accessories; Obturator, 17 Fr. (WA2C17BO); Obturator, 1 (May 21, 2026)
  • K252043 — Bipolar applicator CelonProBreath (WB990310); Bipolar applicator CelonProSleep p (September 23, 2025)
  • K231777 — Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessor (August 18, 2023)
  • K221522 — HF-cables (resusable) (January 19, 2023)
  • K223183 — Light-Guide Cables (January 13, 2023)
  • K213207 — Sheath, Stopcock Accessory (December 22, 2021)
  • K203492 — Instrument tray, for semi-rigid ureteroscope (September 15, 2021)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K203682 — Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer an (May 17, 2021)
  • K203277 — Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (April 28, 2021)

Other clearances for product code NWB

  • K222020 — HD-550 Video Endoscope System (September 8, 2022)
  • K211882 — HD-550 Video Endoscope System (April 1, 2022)
  • K173921 — HD-500 Video Endoscope System (September 5, 2018)
  • K133538 — VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCO (August 7, 2014)
  • K100584 — EVIS EXERAII 180 SYSTEM (July 2, 2010)
  • K072957 — EVIS EXERA II 180 SYSTEM (March 18, 2008)
  • K062049 — EVIS EXERA II 180 SYSTEM (September 22, 2006)
  • K051645 — EVIS EXERA 160A SYSTEM (October 13, 2005)

FDA data resources