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510(k) K133538

VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE by Olympus Corporation of the Americas — Product Code NWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2014
Date Received
November 18, 2013
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 for product code NWB

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  • K100584 — EVIS EXERAII 180 SYSTEM (July 2, 2010)
  • 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)