510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923436Substantially Equivalent

Illuminated Ureteral Catheter

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923436 is the FDA 510(k) clearance record for ILLUMINATED URETERAL CATHETER, a class II device, cleared for Cook Urological, Inc. on under FDA product code FCS (Light, Catheter, Fiberoptic, Glass, Ureteral). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show one recall naming K923436.

Clearance record

Decision date
Received
(235 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
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
510(k) summary
Summary
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