510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082813Substantially Equivalent

Stryker LED Lightsource

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

K082813 is the FDA 510(k) clearance record for STRYKER LED LIGHTSOURCE, a class II device, cleared for Stryker Corp. on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list 568 510(k) clearances for Stryker Corp., from to . As of , FDA records show one recall naming K082813.

Clearance record

Decision date
Received
(86 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
Regulation
21 CFR 876.1500
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 FCW

Trailing 12 months

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

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