510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K091767Substantially Equivalent

3 Way Silicone Foley Balloon Catheter

Cook Incorporated, Spencer IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091767 is the FDA 510(k) clearance record for 3 WAY SILICONE FOLEY BALLOON CATHETER, a class II device, cleared for Cook Urological, Inc. on under FDA product code EZL (Catheter, Retention Type, Balloon). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K091767.

Clearance record

Decision date
Received
(114 days to decision)
Product code
EZL Catheter, Retention Type, Balloon
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 PDF
Third party review
No

Clearances, product code EZL

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