510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962413Substantially Equivalent

Comfort Cath Special Self Adhering Male External Catheter

Sierra Laboratories, Inc., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962413 is the FDA 510(k) clearance record for COMFORT CATH SPECIAL SELF ADHERING MALE EXTERNAL CATHETER, a class I device, cleared for Sierra Laboratories, Inc. on under FDA product code EXJ (Device, Incontinence, Urosheath Type, Sterile). FDA records list 12 510(k) clearances for Sierra Laboratories, Inc., from to . As of , FDA records show no recalls naming K962413.

Clearance record

Decision date
Received
(24 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
Sierra Laboratories, Inc. 3520 S. Campbell Ave., Tucson AZ
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