K202665 is an FDA 510(k) clearance for the Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm. 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 October 15, 2020, 31 days after receiving the submission on September 14, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K202665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2020 |
| Decision Date | October 15, 2020 |
| Days to Decision | 31 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 |