K071920 is an FDA 510(k) clearance for the AUTOSUTURE ABSORBABLE TACK AND APPLICATOR, a Staple, Implantable (Class II — Special Controls, product code GDW), submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on September 28, 2007, 78 days after receiving the submission on July 12, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K071920 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 12, 2007 |
| Decision Date | September 28, 2007 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GDW — Staple, Implantable |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4750 |