510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K942941Substantially Equivalent

Conquest Male Continence System

Convatec, A Bristol-Myers Squibb Co., Princeton NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K942941 is the FDA 510(k) clearance record for CONQUEST MALE CONTINENCE SYSTEM, a class I device, cleared for Convatec, A Bristol-Myers Squibb Co. on under FDA product code EXJ (Device, Incontinence, Urosheath Type, Sterile). FDA records list 10 510(k) clearances for Convatec, A Bristol-Myers Squibb Co., from to . As of , FDA records show no recalls naming K942941.

Clearance record

Decision date
Received
(268 days to decision)
Product code
EXJ Device, Incontinence, Urosheath Type, Sterile
Regulation
21 CFR 876.5250
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Convatec, A Bristol-Myers Squibb Co. P.O. Box Cn 5254, Princeton NJ
510(k) summary
Summary
Third party review
No

Clearances, product code EXJ

Trailing 12 months

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

FDA records show no clearances under product code EXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EXJ, 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