K771435 is an FDA 510(k) clearance for the URINARY LEG BAG, STEOILE. This device is classified as a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II - Special Controls, product code KNX).
Submitted by Meddev International Corp. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1977, 50 days after receiving the submission on August 1, 1977.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K771435 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 1977 |
| Decision Date | September 20, 1977 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNX — Collector, Urine, (and Accessories) For Indwelling Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5250 |