K213633 is an FDA 510(k) clearance for the ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler, a Stapler, Surgical (Class II — Special Controls, product code GAG), submitted by Ethicon Endo-Surgery, LLC (Guaynabo, US). The FDA issued a Cleared decision on April 8, 2022, 142 days after receiving the submission on November 17, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4740.
| 510(k) Number | K213633 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 17, 2021 |
| Decision Date | April 08, 2022 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GAG — Stapler, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4740 |
| Definition | A Surgical Stapler For Internal Use Is A Specialized Prescription Device Used To Deliver Compatible Staples To Internal Tissues During Surgery For Resection, Transection, And Creating Anastomoses. |