K183435 is an FDA 510(k) clearance for the Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black, 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 February 6, 2019, 57 days after receiving the submission on December 11, 2018. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K183435 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 11, 2018 |
| Decision Date | February 06, 2019 |
| Days to Decision | 57 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 |