K031351 is an FDA 510(k) clearance for the FLEX-NECK PD CATHETER, INFANT, a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Medigroup, Inc. (Naperville, US). The FDA issued a Cleared decision on September 17, 2003, 141 days after receiving the submission on April 29, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K031351 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 29, 2003 |
| Decision Date | September 17, 2003 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJS — Catheter, Peritoneal, Long-term Indwelling |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5630 |