510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K924407Substantially Equivalent

Conveen(r) Self-Sealing Urisheath Male Exter Cath

MEDLINE INDUSTRIES, LP - Northfield, Fort Woth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K924407 is the FDA 510(k) clearance record for CONVEEN(R) SELF-SEALING URISHEATH MALE EXTER CATH, a class I device, cleared for Coloplast A/S on under FDA product code EXJ (Device, Incontinence, Urosheath Type, Sterile). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K924407.

Clearance record

Decision date
Received
(29 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
Coloplast A/S C/O Richard Hamer Assoc.Inc., Fort Woth TX
510(k) summary
Statement
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EXJ, 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