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510(k) K062049

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2006
Date Received
July 20, 2006
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

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  • K211882 — HD-550 Video Endoscope System (April 1, 2022)
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  • K133538 — VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCO (August 7, 2014)
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  • K090980 — HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (June 29, 2009)
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