K924406 is an FDA 510(k) clearance for the CONVEEN(R) LEG BAG(500 ML). This device is classified as a Bag, Urine Collection, Leg, For External Use, Sterile (Class I - General Controls, product code FAQ).
Submitted by Coloplast A/S (Fort Woth, US). The FDA issued a Cleared decision on October 30, 1992, 66 days after receiving the submission on August 25, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K924406 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1992 |
| Decision Date | October 30, 1992 |
| Days to Decision | 66 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FAQ — Bag, Urine Collection, Leg, For External Use, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5250 |