K964745 is an FDA 510(k) clearance for the AMSINO URINARY DRAINAGE BAG. This device is classified as a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II - Special Controls, product code KNX).
Submitted by Amsino Intl., Inc. (Pomona, US). The FDA issued a Cleared decision on March 18, 1997, 112 days after receiving the submission on November 26, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K964745 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 26, 1996 |
| Decision Date | March 18, 1997 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |