FDA 510(k)

GIA™ Stapler with Tri-Staple™ Technology

Número K: K231934 · 2023-10-27

Data da decisão2023-10-27

Código do produtoGAG

Comité consultivoHO

DecisãoSubstantially Equivalent

Resumo do dispositivo

GIA™ Stapler with Tri-Staple™ Technology is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K231934. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GIA™ Stapler with Tri-Staple™ Technology?

GIA™ Stapler with Tri-Staple™ Technology is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Covidien. The 510(k) number is K231934.

When did GIA™ Stapler with Tri-Staple™ Technology receive FDA 510(k) clearance?

GIA™ Stapler with Tri-Staple™ Technology received FDA 510(k) clearance on 2023-10-27, under 510(k) number K231934.

Who is the listed applicant for GIA™ Stapler with Tri-Staple™ Technology?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GIA™ Stapler with Tri-Staple™ Technology?

The FDA product code for GIA™ Stapler with Tri-Staple™ Technology is GAG.

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Dispositivos Relacionados (Código: GAG)

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLC K251482AEON® Endoscopic Powered StaplerLexington Medical, Inc.K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 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)Ethicon Endo-Surgery, LLC K234039AEON Endoscopic Powered Stapler (Curto/AEPH060); AEON Endoscopic Powered Stapler (Médio/AEPH160); AEON Endoscopic Powered Stapler (Longo/AEPH260)Lexington Medical, Inc.

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