510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K043022Substantially Equivalent

Stryker Flexible Cystonephroscope

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

K043022 is the FDA 510(k) clearance record for STRYKER FLEXIBLE CYSTONEPHROSCOPE, a class II device, cleared for Stryker Endoscopy on under FDA product code FAJ (Cystoscope And Accessories, Flexible/Rigid). FDA's definition for product code FAJ reads: "To examine and perform 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) submission (82 FR 26807...". FDA records list 568 510(k) clearances for STRYKER CORP., from to . As of , FDA records show no recalls naming K043022.

Clearance record

Decision date
Received
(132 days to decision)
Product code
FAJ Cystoscope 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 FAJ

Trailing 12 months
5 clearances under product code FAJ in the twelve months to November 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code FAJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20262
May 20262
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260