510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K181977Substantially Equivalent

WiScope Digital Endoscope System

OTU Medical Inc, San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K181977 is the FDA 510(k) clearance record for WiScope Digital Endoscope System, a class II device, cleared for OTU Medical, Inc. on under FDA product code FGB (Ureteroscope And Accessories, Flexible/Rigid). FDA's definition for product code FGB reads: "To perform various diagnostic and therapeutic procedures within the urinary tract. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k)...". FDA records list 5 510(k) clearances for OTU Medical, Inc., from to . As of , FDA records show no recalls naming K181977.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FGB Ureteroscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
OTU Medical, Inc. 2231 A Fortune Dr., San Jose CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code FGB

Trailing 12 months
11 clearances under product code FGB in the twelve months to October 2026, August 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FGB, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20263
September 20262
October 20260