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FDA 510(k)

Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads

Número K: K253657 · 2026-04-10

RequerenteCovidien (Part of Medtronic)
Data da decisão2026-04-10
Código do produtoGDW
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads is the device name listed in this FDA 510(k) record. The listed applicant is Covidien (Part of Medtronic). It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K253657. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads?

Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Covidien (Part of Medtronic). The 510(k) number is K253657.

When did Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads receive FDA 510(k) clearance?

Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads received FDA 510(k) clearance on 2026-04-10, under 510(k) number K253657.

Who is the listed applicant for Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads?

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

What is the FDA product code for Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads?

The FDA product code for Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter Reloads is GDW.

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Dispositivos Relacionados (Código: GDW)

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