K972100 is an FDA 510(k) clearance for the VENTED EXTERNAL MALE URINARY CATHETER(VENTED CATH 5000). This device is classified as a Device, Incontinence, Urosheath Type, Sterile (Class I - General Controls, product code EXJ).
Submitted by Advanced Care Medical Products (Novato, US). The FDA issued a Cleared decision on July 31, 1997, 57 days after receiving the submission on June 4, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K972100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 1997 |
| Decision Date | July 31, 1997 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXJ — Device, Incontinence, Urosheath Type, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |