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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

K133538 is an FDA 510(k) premarket notification submitted by Olympus Corporation of the Americas for the device "VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE". The FDA issued a decision of Substantially Equivalent on August 7, 2014. The device falls under product code NWB (Endoscope, Accessories, Narrow Band Spectrum), a Class II device regulated under 21 CFR 876.1500.

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

  • 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)
  • 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)

FDA data resources