K953767 is an FDA 510(k) clearance for the PROSYS BEDSIDE DRAINAGE BAG. This device is classified as a Bag, Urine Collection, Leg, For External Use, Sterile (Class I - General Controls, product code FAQ).
Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on December 20, 1995, 131 days after receiving the submission on August 11, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K953767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1995 |
| Decision Date | December 20, 1995 |
| Days to Decision | 131 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FAQ — Bag, Urine Collection, Leg, For External Use, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |