K242679 is an FDA 510(k) clearance for the Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series). This device is classified as a Staple, Implantable (Class II - Special Controls, product code GDW).
Submitted by Fengh Medical Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on October 4, 2024, 28 days after receiving the submission on September 6, 2024.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4750.
| 510(k) Number | K242679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 2024 |
| Decision Date | October 04, 2024 |
| Days to Decision | 28 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 |