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FDA 510(k)

ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

K-Number: K091900 · 2009-07-16

ApplicantCovidien Lp, Formerly Registered AS United States
Decision Date2009-07-16
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Covidien Lp, Formerly Registered AS United States. It received FDA 510(k) clearance on 2009-07-16 under 510(k) number K091900. 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 ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE?

ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE is a medical device that received FDA 510(k) clearance on 2009-07-16. The listed applicant is Covidien Lp, Formerly Registered AS United States. The 510(k) number is K091900.

When did ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE receive FDA 510(k) clearance?

ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE received FDA 510(k) clearance on 2009-07-16, under 510(k) number K091900.

Who is the listed applicant for ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE?

The FDA 510(k) record lists Covidien Lp, Formerly Registered AS United States as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE?

The FDA product code for ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE is GDW.

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Related Devices (Code: GDW)

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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.

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