510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K880100Substantially Equivalent

Cook Urological Wire Guide W/hydromer Coating

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

K880100 is the FDA 510(k) clearance record for COOK UROLOGICAL WIRE GUIDE W/HYDROMER COATING, a class II device, cleared for Cook Urological, Inc. on under FDA product code KOD (Catheter, Urological). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K880100.

Clearance record

Decision date
Received
(63 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Cook Urological, Inc. 1100 W. Morgan St., Spencer IN
Third party review
No

Clearances, product code KOD

Trailing 12 months
1 clearance under product code KOD in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260