Product Code: GAG FDA class 2 21 CFR 878.4740

Stapler, Surgical

General Hospital

The Surgical Stapler (product code GAG) is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification demonstrating substantial equivalence to a legally marketed predicate device. The device is regulated under 21 CFR 878.4740 in the General Hospital specialty (HO). No special flags apply to this device.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: GAG
Device Class: FDA class 2
Regulation Number: 878.4740
Medical Specialty: General Hospital
Review Panel: SU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

A surgical stapler for internal use is a specialized prescription device used to deliver compatible staples to internal tissues during surgery for resection, transection, and creating anastomoses.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 42 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251482	AEON Endoscopic Powered Stapler	Jul 11, 2025	Substantially Equivalent	Lexington Medical, Inc.
K243596	da Vinci SP SureForm 45 Staplers and Reloads (SP1098)	Mar 10, 2025	Substantially Equivalent	Intuitive Surgical, Inc.
K240881	Signia Circular Adapter (Standard Length) (SIGCIRSTND); Signia Circular Adapter XL Length (SIGCIRXL)	Nov 01, 2024	Substantially Equivalent	Covidien (Part of Medtronic)
K241629	ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)	Jul 03, 2024	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K234039	AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Powered Stapler (Long/AEPH260)	May 07, 2024	Substantially Equivalent	Lexington Medical, Inc.
K231934	GIA Stapler with Tri-Staple Technology	Oct 27, 2023	Substantially Equivalent	Covidien
K232126	EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler Anvil	Aug 16, 2023	Substantially Equivalent	Covidien
K231491	TA Stapler and Loading Unit with DST Series Technology	Aug 16, 2023	Substantially Equivalent	Covidien
K221629	Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)	Feb 22, 2023	Substantially Equivalent	Covidien
K213633	ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler	Apr 08, 2022	Substantially Equivalent	Ethicon Endo-Surgery, LLC
K970079	PROXIMATE DISPOSABLE SKIN STAPLER	Mar 11, 1997	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K962258	ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP	Sep 11, 1996	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K934188	DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART	Mar 28, 1994	Substantially Equivalent	Deroyal Industries, Inc.
K934105	DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES	Mar 28, 1994	Substantially Equivalent	Surgical Innovations Corp.
K932476	PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER	Dec 01, 1993	Substantially Equivalent	Ethicon Endo-Surgery, Inc.
K933901	REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)	Nov 19, 1993	Substantially Equivalent	Richard-Allan Medical
K926127	SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM	Jun 24, 1993	Substantially Equivalent	Life Medical Sciences, Inc.
K892927	PROXIMATE LINEAR CUTTER THICK TISSUE INST.	May 26, 1989	Substantially Equivalent	ETHICON, Inc.
K884404	HERNIASTAT	Nov 08, 1988	Substantially Equivalent	Innovative Surgical Devices Corp.
K862772	V. MUELLER (R) GOOSENECK CIRCULAR STAPLER	Aug 18, 1986	Substantially Equivalent	American V. Mueller
K851258	WECK LX TM SKIN STAPLER	Jun 07, 1985	Substantially Equivalent	Edward Weck, Inc.
K851121	PI-PHEUMO INTESTINAL INSTRUMENT SET	Apr 25, 1985	Substantially Equivalent	Surgeons Choice, Inc.
K850947	V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS	Apr 17, 1985	Substantially Equivalent	American V. Mueller
K844417	APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE	Dec 17, 1984	Substantially Equivalent	Davis & Geck, Inc.
K844628	V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET	Dec 14, 1984	Substantially Equivalent	American V. Mueller
K840178	APPOSE DISPOS. SKIN STAPLER W/AUTO	Mar 05, 1984	Substantially Equivalent	Davis & Geck, Inc.
K840177	APPOSE ULE STERILE DISPOS. SKIN STAP	Mar 05, 1984	Substantially Equivalent	Davis & Geck, Inc.
K834138	HYPO SUTURE	Jan 27, 1984	Substantially Equivalent	Medical Design & Manufacturing Corp.
K830741	PARAMETRIC STERILITY RELEASE OF AUTO	Aug 11, 1983	Substantially Equivalent	United Surgical Corp.
K823776	PI-PNEUMO-INTESTINAL INSTRUMENT SET	Jan 14, 1983	Substantially Equivalent	Surgeons Choice, Inc.
K820811	PROXIMATE DISPOSABLE SKIN STAPLERS	Aug 20, 1982	Substantially Equivalent	ETHICON, Inc.
K821228	DEKNATEL SKIN STAPLE EXTRACTOR	May 14, 1982	Substantially Equivalent	Howmedica Corp.
K813170	ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER	Feb 12, 1982	Substantially Equivalent	Surgeons Choice, Inc.
K811030	APPOSE SKIN STAPLER	May 27, 1981	Substantially Equivalent	Davis & Geck, Inc.
K803038	PROXIMATE*II DISPOSABLE SKIN STAPLER	Dec 30, 1980	Substantially Equivalent	ETHICON, Inc.
K802611	AUTO SUTURE DISPOS., EEA SURG. STAPLER	Nov 12, 1980	Substantially Equivalent	U. S. Surgical Corp.
K801445	SKIN STAPLER HANDLE 523700/CARTRIDGES	Jul 14, 1980	Substantially Equivalent	Edward Weck, Inc.
K771619	PROXIMATE DISP. SKIN STAPLER	Nov 15, 1977	Substantially Equivalent	ETHICON, Inc.
K771177	SURGICAL STAPLING INSTRU., AUTO, SUTURE	Oct 18, 1977	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K771113	AUTO SUTURE R CLIP INSTRUMENT	Sep 30, 1977	Substantially Equivalent	United States Surgical, A Division of Tyco Healthc
K760733	SKIN STAPLE EXTRACTOR	Nov 03, 1976	Substantially Equivalent	ETHICON, Inc.
K760732	SKIN STAPLING INSTRUMENT	Nov 03, 1976	Substantially Equivalent	ETHICON, Inc.