510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121112Substantially Equivalent

Stryker Video Ureteroscope

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

K121112 is the FDA 510(k) clearance record for STRYKER VIDEO URETEROSCOPE, a class II device, cleared for Stryker Endoscopy 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 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show no recalls naming K121112.

Clearance record

Decision date
Received
(153 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
Stryker Endoscopy 5900 Optical Ct., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FGB

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