K971271 is an FDA 510(k) clearance for the BESECURE EXTERNAL URINARY COLLECTION SYSTEM, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Urology Research Intl., Inc. (Cleveland, US). The FDA issued a Cleared decision on August 18, 1997, 136 days after receiving the submission on April 4, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.
| 510(k) Number | K971271 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 1997 |
| Decision Date | August 18, 1997 |
| Days to Decision | 136 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 |