Medical Device
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K133538Substantially Equivalent

Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope Olympus Cyf Type Va2, Visera Cysto-Ne

OLYMPUS Corporation of the Americas, Center Valley PA / Traditional, Substantially Equivalent

K133538 is the FDA 510(k) clearance record for VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE, a class II device, cleared for Olympus Corporation of the Americas on under FDA product code NWB (Endoscope, Accessories, Narrow Band Spectrum). FDA's definition for product code NWB reads: "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". FDA records list 150 510(k) clearances for Olympus Corporation of the Americas, from to . As of , FDA records show no recalls naming K133538.

Clearance record

Decision date
Received
(262 days to decision)
Product code
NWB Endoscope, Accessories, Narrow Band Spectrum
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Olympus Corporation of the Americas 3500 Corporate Pkwy., Center Valley PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NWB

Trailing 12 months

FDA records hold no clearances under product code NWB in the trailing twelve months.

FDA records show no clearances under product code NWB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NWB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260