Cleared Traditional

K202709 - Disposable Powered Endoscopic Linear Cu...

K202709 is an FDA 510(k) clearance for Disposable Powered Endoscopic Linear Cu..., manufactured by Ningbo Verykind Medical Device Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GDW cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K202709 · Ningbo Verykind Medical Device Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K202709

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.

GDW Device Classification - Class 2, Special Controls

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 164
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