K020804 is an FDA 510(k) clearance for the AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER, 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 November 19, 2002, 252 days after receiving the submission on March 12, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K020804 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 12, 2002 |
| Decision Date | November 19, 2002 |
| Days to Decision | 252 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 |