Skip to content

Disposable Circular Stapler

by Changzhou City Zhiye Medical Devices Institute Co.

510(k) K131303

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK131303 Date11 Jun 2013ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 19 Sep 2026

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

The Disposable Circular Stapler is a medical device designed for stapling applications in surgical procedures. It is a single-use device that provides a circular stapling mechanism for tissue approximation.

The device is supplied as a sterile, single-use product and is not intended for reuse. It is regulated under FDA 510(k) clearance with product code GDW and is classified as a Class II medical device. The device is available in various models including YH-26.

Questions

AI-generated answers, 19 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 is the Disposable Circular Stapler used for in surgical procedures?

    The Disposable Circular Stapler is designed for stapling applications in surgical procedures to provide tissue approximation. It is specifically intended for use in general and plastic surgery procedures.

  • Is the Disposable Circular Stapler reusable or single-use?

    The Disposable Circular Stapler is a single-use device that is not intended for reuse. It is supplied as a sterile, single-use product and should be discarded after one surgical procedure.

  • What models of the Disposable Circular Stapler are available?

    The Disposable Circular Stapler is available in various models, including the YH-26 model. Different models may be designed for specific surgical applications or tissue thicknesses.

  • How is the Disposable Circular Stapler supplied?

    The Disposable Circular Stapler is supplied as a sterile, single-use product. It comes ready for use in surgical procedures without the need for additional sterilization by the user.

  • What is the regulatory classification of the Disposable Circular Stapler?

    The Disposable Circular Stapler is regulated under FDA 510(k) clearance with product code GDW and is classified as a Class II medical device. It received traditional 510(k) clearance with a decision code of SESE.