Cleared Special

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)

K242679 · Fengh Medical Co., Ltd. · General & Plastic Surgery
Oct 2024
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K242679 is an FDA 510(k) clearance for the 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), 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 review panel. Regulated under 21 CFR 878.4750.

Submission Details

510(k) Number K242679 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code GDW — Staple, Implantable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4750

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