Cleared Traditional

Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges (K202709) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202709 · Ningbo Verykind Medical Device Co., Ltd. · General & Plastic Surgery device
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May 2021
Decision
244d
Days
Class 2
Risk

K202709 is an FDA 510(k) clearance for the Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges. Classified as Staple, Implantable (product code GDW), Class II - Special Controls.

Submitted by Ningbo Verykind Medical Device Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on May 18, 2021 after a review of 244 days - an extended review cycle.

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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ningbo Verykind Medical Device Co., Ltd. devices

Submission Details

510(k) Number K202709 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2020
Decision Date May 18, 2021
Days to Decision 244 days
Submission Type Traditional
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
129d slower than avg
Panel avg: 115d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Shenzhen Joyantech Consulting Co., Ltd.
James Tsai

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 128
Devices cleared under the same product code (GDW) and FDA review panel - the closest regulatory comparables to K202709.
Surgimatix Absorbable Fixation System
K201934 · Surgimatix, Inc. · Oct 2021
easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use
K210909 · Ezisurg Medical Co., Ltd. · Jun 2021
Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads
K201639 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · May 2021
Titan SGS
K210278 · Standard Bariatrics · Apr 2021
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