FDA 510(k) Applications for Medical Device Product Code "GAG"
(Stapler, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K232126 Covidien EEAÖCircular Stapler with Tri-StapleÖ Technology and OrVilÖ Transoral Circular Stapler Anvil 08/16/2023
K231491 Covidien TAÖ Stapler and Loading Unit with DST SeriesÖ Technology 08/16/2023
K221629 Covidien Tri-StapleÖ 2.0 Black Circular Reloads (for use with SigniaÖ Circular Adapters) 02/22/2023
K962258 ETHICON ENDO-SURGERY, INC. ENDOPATH ENDOSCOPIC ARTICULATING STAPLER WITH SWEIVELING CARTRIDGE TIP 09/11/1996
K970079 ETHICON ENDO-SURGERY, INC. PROXIMATE DISPOSABLE SKIN STAPLER 03/11/1997
K213633 Ethicon Endo-Surgery, LLC ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler 04/08/2022


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