FDA 510(k)

Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)

K-Number: K221629 · 2023-02-22

Decision Date2023-02-22

Product CodeGAG

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2023-02-22 under approval number K221629. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)?

Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) is a medical device that received FDA 510(k) clearance on 2023-02-22. It is manufactured by Covidien. The 510(k) number is K221629.

When was Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) approved by the FDA?

Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) received FDA 510(k) clearance on 2023-02-22, under approval number K221629.

What company makes Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)?

Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) is manufactured by Covidien.

What is the FDA product code for Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)?

The FDA product code for Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters) is GAG.

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Related Devices (Code: GAG)

K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC K231934GIA Stapler with Tri-Staple TechnologyCovidien K231491TA Stapler and Loading Unit with DST Series TechnologyCovidien K232126EEACircular Stapler with Tri-Staple Technology and OrVil Transoral Circular Stapler AnvilCovidien 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

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.