K241629 is an FDA 510(k) clearance for the ECHELON 3000 45mm Compact Stapler (ECH45C). This device is classified as a Stapler, Surgical (Class II - Special Controls, product code GAG).
Submitted by Ethicon Endo-Surgery, LLC (Guaynabo, PR). The FDA issued a Cleared decision on July 3, 2024, 27 days after receiving the submission on June 6, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4740. 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..
| 510(k) Number | K241629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2024 |
| Decision Date | July 03, 2024 |
| Days to Decision | 27 days |
| Submission Type | Special |
| 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. |