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Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges

by Ningbo Verykind Medical Device Co., Ltd.

510(k) K202709

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K202709↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK202709 Date18 May 2021ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
GDW
Device Class
Class II
Regulation
21 CFR Part 878.4750
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Disposable Powered Endoscopic Linear Cutting Stapler and associated cartridges, classified under FDA product code GDW (General and Plastic Surgery). It is designed for endoscopic surgical procedures to excise or anastomose tissue by cutting and stapling in a single action, reducing the need for manual suturing. The system combines a reusable endoscopic stapler handle with single-use, disposable cartridge assemblies containing staples and a cutting edge.

The device is intended for single-use only and must be discarded after one procedure to maintain sterility. Supplied sterile in a sealed package, it is regulated under FDA 510(k) clearance (K202709) and the EU MDR. Cartridges are available in multiple sizes and configurations, as referenced by the listed FEI numbers, to accommodate varying tissue thicknesses and anatomical requirements. No MRI safety information is specified, and proper handling, storage, and disposal per manufacturer instructions are required.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is this device designed for, and how does it reduce manual effort during surgery?

    This device is designed for endoscopic surgical procedures, specifically to excise tissue (remove it) or anastomose tissue (connect two ends of a structure like the intestine). It achieves this by cutting and stapling in a single action, eliminating the need for manual suturing. This streamlines the procedure by automating the stapling process, reducing surgical time and potential human error.

  • Are the cartridges reusable, or do they need to be discarded after a single use? Why?

    The cartridges are intended for single-use only and must be discarded after one procedure to maintain sterility. Since they contain staples and a cutting edge, reusing them could compromise patient safety by introducing contamination or mechanical failure risks.

  • How do I know which cartridge size to use for a specific patient or anatomical requirement?

    The cartridges come in multiple sizes, each referenced by unique FEI numbers (e.g., 3011052945, 3003495548). These sizes accommodate varying tissue thicknesses and anatomical needs. The manufacturer’s instructions should guide selection based on the specific surgical context, ensuring proper fit and functionality.

  • How should the device be stored to ensure it remains sterile and functional?

    The device is supplied sterile in a sealed package, so it must be stored in its original packaging until ready for use. Storage should follow manufacturer guidelines to preserve sterility and prevent damage, including protection from moisture, extreme temperatures, and physical stress.

  • What regulatory pathways has this device undergone, and how does that affect its use?

    This device has received FDA 510(k) clearance (K202709) and EU MDR compliance, confirming it meets regulatory standards for safety and effectiveness. These clearances ensure the device adheres to stringent manufacturing, performance, and labeling requirements, but they do not dictate clinical indications—only the manufacturer’s intended use (endoscopic cutting/stapling) applies.