K140560 is an FDA 510(k) clearance for the ECHELON FLEX POWERED PLUS ARTICULATING ENDOSCOPIC LINEAR CUTTER, 60MM, STANDARD, ECHELON FLEX POWERED PLUS ARTICULATING. This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Ethicon Endo-Surgery, LLC (Cincinnati, US). The FDA issued a Cleared decision on April 22, 2014, 48 days after receiving the submission on March 5, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K140560 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2014 |
| Decision Date | April 22, 2014 |
| Days to Decision | 48 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 |