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FDA 510(k)

Tri-Staple 2.0 Intelligent Cartridge

K-Number: K163098 · 2016-12-05

ApplicantCovidien, LLC
Decision Date2016-12-05
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tri-Staple 2.0 Intelligent Cartridge is a medical device manufactured by Covidien, LLC. It received FDA 510(k) clearance on 2016-12-05 under approval number K163098. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tri-Staple 2.0 Intelligent Cartridge?

Tri-Staple 2.0 Intelligent Cartridge is a medical device that received FDA 510(k) clearance on 2016-12-05. It is manufactured by Covidien, LLC. The 510(k) number is K163098.

When was Tri-Staple 2.0 Intelligent Cartridge approved by the FDA?

Tri-Staple 2.0 Intelligent Cartridge received FDA 510(k) clearance on 2016-12-05, under approval number K163098.

What company makes Tri-Staple 2.0 Intelligent Cartridge?

Tri-Staple 2.0 Intelligent Cartridge is manufactured by Covidien, LLC.

What is the FDA product code for Tri-Staple 2.0 Intelligent Cartridge?

The FDA product code for Tri-Staple 2.0 Intelligent Cartridge is GDW.

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Official Source

View on FDA Database →

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

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