K242679

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)

510(k) number
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. CN
Product code
GDW — Staple, Implantable
Decision date
2024-10-04
Date received
2024-09-06
Decision
Substantially Equivalent
Clearance type
Special
Advisory committee
General, Plastic Surgery
510(k) Summary (official FDA PDF): K242679.pdf
Official FDA record: K242679
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.