K071406 is an FDA 510(k) clearance for the AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER, a Clip, Implantable (Class II — Special Controls, product code FZP), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on November 21, 2007, 184 days after receiving the submission on May 21, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K071406 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 21, 2007 |
| Decision Date | November 21, 2007 |
| Days to Decision | 184 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4300 |