K182475 is an FDA 510(k) clearance for the Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters). This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Covidien (North Haven, US). The FDA issued a Cleared decision on March 14, 2019, 185 days after receiving the submission on September 10, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K182475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2018 |
| Decision Date | March 14, 2019 |
| Days to Decision | 185 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 |