FDA 510(k)

ABSORBATACK 5MM SINGLE USE ABSORBABLE FIXATION DEVICE

K-Number: K123109 · 2012-10-23

Decision Date2012-10-23

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. It received FDA 510(k) clearance on 2012-10-23 under 510(k) number K123109. 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 2012-10-23. The listed applicant is Covidien. The 510(k) number is K123109.

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 2012-10-23, under 510(k) number K123109.

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

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 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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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.