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FDA 510(k)

GIA Auto Suture Stapler with DST Series Technology

K-Number: K221013 · 2022-05-05

ApplicantCovidien
Decision Date2022-05-05
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GIA Auto Suture Stapler with DST Series Technology is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221013. 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 GIA Auto Suture Stapler with DST Series Technology?

GIA Auto Suture Stapler with DST Series Technology is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Covidien. The 510(k) number is K221013.

When did GIA Auto Suture Stapler with DST Series Technology receive FDA 510(k) clearance?

GIA Auto Suture Stapler with DST Series Technology received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221013.

Who is the listed applicant for GIA Auto Suture Stapler with DST Series 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 Auto Suture Stapler with DST Series Technology?

The FDA product code for GIA Auto Suture Stapler with DST Series Technology is GDW.

Other records listing Covidien as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 119 devices →

Related Devices (Code: GDW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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