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FDA 510(k)

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

K-Number: K182475 · 2019-03-14

ApplicantCovidien
Decision Date2019-03-14
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2019-03-14 under approval number K182475. 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 Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters)?

Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Covidien. The 510(k) number is K182475.

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

Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) received FDA 510(k) clearance on 2019-03-14, under approval number K182475.

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

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

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

The FDA product code for Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) is GDW.

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Related Devices (Code: 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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