510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K061548Substantially Equivalent

Stryker Ureteral Illumination System IV

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

K061548 is the FDA 510(k) clearance record for STRYKER URETERAL ILLUMINATION SYSTEM IV, a class II device, cleared for Stryker Corp. on under FDA product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show no recalls naming K061548.

Clearance record

Decision date
Received
(115 days to decision)
Product code
FCS Light, Catheter, Fiberoptic, Glass, Ureteral
Regulation
21 CFR 876.4020
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Stryker Corp. 5900 Optical Ct., San Jose CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FCS

Trailing 12 months

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

FDA records show no clearances under product code FCS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCS, 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