510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972100Substantially Equivalent

Vented External Male Urinary Catheter(vented Cath 5000)

Advanced Care Medical Products, Novato CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972100 is the FDA 510(k) clearance record for VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000), a class I device, cleared for Advanced Care Medical Products on under FDA product code EXJ (Device, Incontinence, Urosheath Type, Sterile). FDA records list one 510(k) clearance for Advanced Care Medical Products. As of , FDA records show no recalls naming K972100.

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
Advanced Care Medical Products 385 Bel Marin Keys Blvd. #J, Novato CA
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