K030712 is an FDA 510(k) clearance for the AMSURE URETHRAL CATHETERIZATION TRAY. 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. (Ontario, US). The FDA issued a Cleared decision on May 23, 2003, 78 days after receiving the submission on March 6, 2003.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K030712 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2003 |
| Decision Date | May 23, 2003 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |