ClearanceBrief
Panels › General Hospital › Product code GAG · Class 2

Stapler, Surgical

Regulation 878.4740

1510(k)s in 12 months (43 all time)
0recalls in 12 months (10 all time)
5recalls that name a 510(k)
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Top companies in GAG

Decided510(k)Device and applicantCode
Jul 1, 2026K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Th
Covidien, LLC
GAG
Jul 11, 2025K251482AEON™ Endoscopic Powered Stapler
Lexington Medical, Inc.
GAG
Mar 10, 2025K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)
Intuitive Surgical, Inc.
GAG
Nov 1, 2024K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)
Covidien (Part of Medtronic)
GAG
Jul 3, 2024K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler
Ethicon Endo-Surgery, LLC, PR
GAG
May 7, 2024K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler (Medium/AEPH160); AEON Endoscopic Power
Lexington Medical, Inc.
GAG
Oct 27, 2023K231934GIA™ Stapler with Tri-Staple™ Technology
Covidien, CN
GAG
Aug 16, 2023K232126EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil
Covidien, CN
GAG
Aug 16, 2023K231491TA™ Stapler and Loading Unit with DST Series™ Technology
Covidien
GAG
Feb 22, 2023K221629Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters)
Covidien
GAG
Apr 8, 2022K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler
Ethicon Endo-Surgery, LLC
GAG
Mar 11, 1997K970079PROXIMATE DISPOSABLE SKIN STAPLER
Ethicon Endo-Surgery, Inc.
GAG
Sep 11, 1996K962258ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP
Ethicon Endo-Surgery, Inc.
GAG
Mar 28, 1994K934188DEROYAL SURG DISP/REUSABLE SKIN STAPLER HANDLE/CART
Deroyal Industries, Inc.
GAG
Mar 28, 1994K934105DISPOS/REUSABLE SURG SKIN/STAINLESS STEEL STAPLES
Surgical Innovations Corp.
GAG
Dec 1, 1993K932476PROXIMATE RELOADABLE ARTICULATING LINEAR STAPLER
Ethicon Endo-Surgery, Inc.
GAG
Nov 19, 1993K933901REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)
Richard-Allan Medical
GAG
Jun 24, 1993K926127SURE-CLOSURE 75MM SKIN STRETCHING SYSTEM
Life Medical Sciences, Inc.
GAG
May 26, 1989K892927PROXIMATE LINEAR CUTTER THICK TISSUE INST.
ETHICON, Inc.
GAG
Nov 8, 1988K884404HERNIASTAT
Innovative Surgical Devices Corp.
GAG
Aug 18, 1986K862772V. MUELLER (R) GOOSENECK CIRCULAR STAPLER
American V. Mueller
GAG
Jun 7, 1985K851258WECK LX TM SKIN STAPLER
Edward Weck, Inc.
GAG
Apr 25, 1985K851121PI-PHEUMO INTESTINAL INSTRUMENT SET
Surgeons Choice, Inc.
GAG
Apr 17, 1985K850947V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS
American V. Mueller
GAG
Dec 17, 1984K844417APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE
Davis & Geck, Inc.
GAG
Dec 14, 1984K844628V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET
American V. Mueller
GAG
Mar 5, 1984K840178APPOSE DISPOS. SKIN STAPLER W/AUTO
Davis & Geck, Inc.
GAG
Mar 5, 1984K840177APPOSE ULE STERILE DISPOS. SKIN STAP
Davis & Geck, Inc.
GAG
Jan 27, 1984K834138HYPO SUTURE
Medical Design & Manufacturing Corp.
GAG
Aug 11, 1983K830741PARAMETRIC STERILITY RELEASE OF AUTO
United Surgical Corp.
GAG
Jan 14, 1983K823776PI-PNEUMO-INTESTINAL INSTRUMENT SET
Surgeons Choice, Inc.
GAG
Aug 20, 1982K820811PROXIMATE DISPOSABLE SKIN STAPLERS
ETHICON, Inc.
GAG
May 14, 1982K821228DEKNATEL SKIN STAPLE EXTRACTOR
Howmedica Corp.
GAG
Feb 12, 1982K813170ILA(INVERTED LINEAR ANASTOMOSIS) STAPLER
Surgeons Choice, Inc.
GAG
May 27, 1981K811030APPOSE SKIN STAPLER
Davis & Geck, Inc.
GAG
Dec 30, 1980K803038PROXIMATE*II DISPOSABLE SKIN STAPLER
ETHICON, Inc.
GAG
Nov 12, 1980K802611AUTO SUTURE DISPOS., EEA SURG. STAPLER
U. S. Surgical Corp.
GAG
Jul 14, 1980K801445SKIN STAPLER HANDLE 523700/CARTRIDGES
Edward Weck, Inc.
GAG
Nov 15, 1977K771619PROXIMATE DISP. SKIN STAPLER
ETHICON, Inc.
GAG
Oct 18, 1977K771177SURGICAL STAPLING INSTRU., AUTO, SUTURE
United States Surgical, A Division of Tyco Healthc
GAG
Sep 30, 1977K771113AUTO SUTURE R CLIP INSTRUMENT
United States Surgical, A Division of Tyco Healthc
GAG
Nov 3, 1976K760733SKIN STAPLE EXTRACTOR
ETHICON, Inc.
GAG
Nov 3, 1976K760732SKIN STAPLING INSTRUMENT
ETHICON, Inc.
GAG

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