Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)
Device Facts
| Record ID | K242679 |
|---|---|
| Device Name | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) |
| Applicant | Fengh Medical Co., Ltd. |
| Product Code | GDW · General, Plastic Surgery |
| Decision Date | Oct 4, 2024 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 878.4750 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.
