Cleared Special

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (K202467) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K202467 · Fengh Medical Co., Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2020
Decision
109d
Days
Class 2
Risk

K202467 is an FDA 510(k) clearance for the Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Fengh Medical Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on December 14, 2020 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4750 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fengh Medical Co., Ltd. devices

Submission Details

510(k) Number K202467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2020
Decision Date December 14, 2020
Days to Decision 109 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GDW Staple, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Shanghai Medical Business Consulting Co., Ltd.
Julie Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GDW Staple, Implantable

All 112
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K202467.
Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
K200320 · M/s. Meril Endo Surgery Private Limited. · Feb 2021
EEA Circular Stapler with Tri-Staple Technology
K202507 · Covidien · Jan 2021
TissueTak device
K203117 · Via Surgical , Ltd. · Jan 2021
GIA Stapler with Tri-Staple Technology
K202701 · Covidien · Dec 2020
Tri-Staple 2.0 Reloads
K202864 · Covidien · Oct 2020
Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm
K202665 · Ethicon Endo-Surgery, LLC · Oct 2020