OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners

Q: What is the product code of K170278?

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

FDA 510(k) K170278 · C.R. Bard, Inc.

Substantially Equivalent

510(k) numberK170278

Submission

Device name: OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners
Applicant: C.R. Bard, Inc.
Warwick, RI, US
Received: January 30, 2017
Decision date: May 31, 2017
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

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Questions and answers

When was OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners cleared by the FDA?

OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners (K170278) received a 510(k) decision of Substantially Equivalent on May 31, 2017, 121 days after the submission was received.

What is the product code of K170278?

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