510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913524Substantially Equivalent

Silicone Male External Catheter

Mentor, Goleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913524 is the FDA 510(k) clearance record for SILICONE MALE EXTERNAL CATHETER, a class I device, cleared for Mentor Corp. on under FDA product code EXJ (Device, Incontinence, Urosheath Type, Sterile). FDA records list 65 510(k) clearances for Mentor Corp., from to . As of , FDA records show no recalls naming K913524.

Clearance record

Decision date
Received
(57 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
Mentor Corp. 600 Pine Ave., Goleta CA
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 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