K120258 is an FDA 510(k) clearance for the DUET TRS RELOADS, DUET TRS RELOADS WITH TRI-STAPLE TECHNOLOGY, ENDO GIA UNIVERSAL AND ULTRA UNIVERSAL STAPLERS. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Covidien, Formerly US Surgical A Divison of Tyco H (North Haven, US). The FDA issued a Cleared decision on February 29, 2012, 33 days after receiving the submission on January 27, 2012.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K120258 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2012 |
| Decision Date | February 29, 2012 |
| Days to Decision | 33 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 |