FDA 510(k)

GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4

K-Number: K092278 · 2009-09-29

Decision Date2009-09-29

Product CodeHIH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 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 2009-09-29 under 510(k) number K092278. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4?

GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 is a medical device that received FDA 510(k) clearance on 2009-09-29. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K092278.

When did GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 receive FDA 510(k) clearance?

GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 received FDA 510(k) clearance on 2009-09-29, under 510(k) number K092278.

Who is the listed applicant for GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4?

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 INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4?

The FDA product code for GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4 is HIH.

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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.