K082831 is an FDA 510(k) clearance for the AMSELF CLOSED CATHETERIZATION SYSTEM. This device is classified as a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II - Special Controls, product code FCM).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on October 23, 2008, 27 days after receiving the submission on September 26, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K082831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2008 |
| Decision Date | October 23, 2008 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |