K160521 is an FDA 510(k) clearance for the ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on March 22, 2016, 26 days after receiving the submission on February 25, 2016.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K160521 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2016 |
| Decision Date | March 22, 2016 |
| Days to Decision | 26 days |
| Submission Type | Special |
| 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 |