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FDA 510(k)

GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT

K-Number: K102970 · 2011-05-20

ApplicantGyrus Acmi, Inc.
Decision Date2011-05-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT 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 2011-05-20 under 510(k) number K102970. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT?

GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT is a medical device that received FDA 510(k) clearance on 2011-05-20. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K102970.

When did GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT receive FDA 510(k) clearance?

GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT received FDA 510(k) clearance on 2011-05-20, under 510(k) number K102970.

Who is the listed applicant for GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT?

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 CYBER WAND-STERILIZATION TRAYS MODEL FGT?

The FDA product code for GYRUS ACMI CYBER WAND-STERILIZATION TRAYS MODEL FGT is KCT.

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Related Devices (Code: KCT)

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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.

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