510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941506Substantially Equivalent

Ureteral Illuminator

CooperSurgical, Inc., Bolton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941506 is the FDA 510(k) clearance record for URETERAL ILLUMINATOR, a class II device, cleared for Apple Medical Corp. on under FDA product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral). FDA records list 103 510(k) clearances for COOPERSURGICAL, INC., from to . As of , FDA records show no recalls naming K941506.

Clearance record

Decision date
Received
(190 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
Apple Medical Corp. 93 Nashaway Rd., Bolton MA
510(k) summary
Statement
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