510(k) K100584

EVIS EXERAII 180 SYSTEM by Olympus Medical Systems Corporation — Product Code NWB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 2, 2010
Date Received: March 2, 2010
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.

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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)
K090980 — HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (June 29, 2009)
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)