510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K972977Substantially Equivalent

Insulator Wire Guide

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

K972977 is the FDA 510(k) clearance record for INSULATOR WIRE GUIDE, a class II device, cleared for Cook Urological, Inc. on under FDA product code KNY (Accessories, Catheter, G-U). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K972977.

Clearance record

Decision date
Received
(60 days to decision)
Product code
KNY Accessories, Catheter, G-U
Regulation
21 CFR 876.5130
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 KNY

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