K060897 is an FDA 510(k) clearance for the EMBEDDING TOOL, MODEL TE-1000, a Catheter, Peritoneal, Long-term Indwelling (Class II — Special Controls, product code FJS), submitted by Medigroup, Inc. (Oswego, US). The FDA issued a Cleared decision on July 18, 2006, 106 days after receiving the submission on April 3, 2006. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.
| 510(k) Number | K060897 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 03, 2006 |
| Decision Date | July 18, 2006 |
| Days to Decision | 106 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 |