510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K930135Substantially Equivalent

Silicone Rectal Balloon

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

K930135 is the FDA 510(k) clearance record for SILICONE RECTAL BALLOON, a class II device, cleared for Cook Urological, Inc. on under FDA product code FEN (Device, Cystometric, Hydraulic). FDA records list 279 510(k) clearances for Cook Incorporated, from to . As of , FDA records show no recalls naming K930135.

Clearance record

Decision date
Received
(269 days to decision)
Product code
FEN Device, Cystometric, Hydraulic
Regulation
21 CFR 876.1620
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 FEN

Trailing 12 months

FDA records hold no clearances under product code FEN in the trailing twelve months.

FDA records show no clearances under product code FEN in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FEN, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260