FDA 510(k)

GYRUS ACMI HALO PKS CUTTING FORCEPS

K-Number: K100896 · 2010-06-17

Decision Date2010-06-17

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

GYRUS ACMI HALO PKS CUTTING FORCEPS is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2010-06-17 under 510(k) number K100896. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ACMI HALO PKS CUTTING FORCEPS?

GYRUS ACMI HALO PKS CUTTING FORCEPS is a medical device that received FDA 510(k) clearance on 2010-06-17. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K100896.

When did GYRUS ACMI HALO PKS CUTTING FORCEPS receive FDA 510(k) clearance?

GYRUS ACMI HALO PKS CUTTING FORCEPS received FDA 510(k) clearance on 2010-06-17, under 510(k) number K100896.

Who is the listed applicant for GYRUS ACMI HALO PKS CUTTING FORCEPS?

The FDA 510(k) record lists Gyrus Acmi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GYRUS ACMI HALO PKS CUTTING FORCEPS?

The FDA product code for GYRUS ACMI HALO PKS CUTTING FORCEPS is GEI.

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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.