FDA 510(k)

AMID STAPLER

K-Number: K120268 · 2012-02-10

Decision Date2012-02-10

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

AMID STAPLER is the device name listed in this FDA 510(k) record. The listed applicant is Safestich Medical, LLC. It received FDA 510(k) clearance on 2012-02-10 under 510(k) number K120268. 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 AMID STAPLER?

AMID STAPLER is a medical device that received FDA 510(k) clearance on 2012-02-10. The listed applicant is Safestich Medical, LLC. The 510(k) number is K120268.

When did AMID STAPLER receive FDA 510(k) clearance?

AMID STAPLER received FDA 510(k) clearance on 2012-02-10, under 510(k) number K120268.

Who is the listed applicant for AMID STAPLER?

The FDA 510(k) record lists Safestich Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMID STAPLER?

The FDA product code for AMID STAPLER is 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.