SignalMark Lung Biopsy Site Marker

Q: What is the product code of K180175?

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

FDA 510(k) K180175 · View Point Medical, Inc.

Substantially Equivalent

510(k) numberK180175

Submission

Device name: SignalMark Lung Biopsy Site Marker
Applicant: View Point Medical, Inc.
San Clemente, CA, US
Received: January 22, 2018
Decision date: December 7, 2018
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
K241762	OneMarkNEU · Traditional	09/16/2024SE
K190689	SignalMark Breast MarkerNEU · Traditional	08/14/2019SE

Questions and answers

When was SignalMark Lung Biopsy Site Marker cleared by the FDA?

SignalMark Lung Biopsy Site Marker (K180175) received a 510(k) decision of Substantially Equivalent on December 7, 2018, 319 days after the submission was received.

What is the product code of K180175?

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