Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge

Q: What is the product code of K161905?

The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.

FDA 510(k) K161905 · Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd

Substantially Equivalent

510(k) numberK161905

Submission

Device name: Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge
Applicant: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd
Changzhou, CN
Received: July 11, 2016
Decision date: November 17, 2016
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: GDW – Staple, Implantable
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.4750
Specialty: General, Plastic Surgery
Implant: Yes

Other 510(k)s with product code GDW

510(k)	Device	Applicant	Decision
K260196	ETHICON Circular Stapler (CDH21mm); ETHICON Circular Stapler (CDH25mm); ETHICON…GDW · Traditional	Ethicon Endo-Surgery, LLC	05/11/2026SE
K253657	Tri-staple 2.0 Reloads; Endo GIA Reloads with Tri-Staple Technology; Endo GIA Gray…GDW · Traditional	Covidien (Part of Medtronic)	04/10/2026SE
K252739	ETHICON 4000 45mm Compact Stapler (EC3DT45C); ETHICON 4000 45mm Standard Stapler…GDW · Traditional	Ethicon Endo-Surgery, LLC	12/17/2025SE
K250835	ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…GDW · Traditional	Ethicon Endo-Surgery, LLC	05/14/2025SE
K243276	ECHELON LINEAR Stapler 30mm Stapler (GTX30); ECHELON LINEAR Stapler 60mm Stapler…GDW · Traditional	Ethicon Endo-Surgery, LLC	02/25/2025SE
K241630	ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…GDW · Traditional	Ethicon Endo-Surgery, LLC	10/28/2024SE
K242679	Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm…GDW · Special	Fengh Medical Co., Ltd.	10/04/2024SE
K222487	Anika Tissue Tack Fixation SystemGDW · Traditional	Anika Therapeutics, Inc.	05/08/2023SE
K222210	AEON Endoscopic StaplerGDW · Traditional	Lexington Medical, Inc.	04/21/2023SE
K223760	ECHELON LINEAR 60 mm Cutter (GLC60);ECHELON LINEAR 80mm Cutter (GLC80);ECHELON LINEAR…GDW · Traditional	Ethicon Endo-Surgery	03/15/2023SE

More from Ethicon Endo-Surgery

510(k)	Device	Decision
K250389	XNY Disposable Gastric Calibration TubeKNT · Traditional	04/10/2025SE
K190029	Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar…GCJ · Traditional	09/26/2019SE

Questions and answers

When was Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge cleared by the FDA?

Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable Linear Stapler, Disposable Endoscopic Linear Cutter Stapler and Cartridge, Disposable Linear Cutter Stapler and Stapler Cartridge (K161905) received a 510(k) decision of Substantially Equivalent on November 17, 2016, 129 days after the submission was received.

What is the product code of K161905?

The FDA product code is GDW – Staple, Implantable, a Class II (moderate risk) device regulated under 21 CFR 878.4750.