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FDA 510(k)

HTx Disposable Hysteroscope System

K-Number: K211227 · 2021-09-15

ApplicantAcuvu, Inc.
Decision Date2021-09-15
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

HTx Disposable Hysteroscope System is a medical device manufactured by Acuvu, Inc.. It received FDA 510(k) clearance on 2021-09-15 under approval number K211227. 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 HTx Disposable Hysteroscope System?

HTx Disposable Hysteroscope System is a medical device that received FDA 510(k) clearance on 2021-09-15. It is manufactured by Acuvu, Inc.. The 510(k) number is K211227.

When was HTx Disposable Hysteroscope System approved by the FDA?

HTx Disposable Hysteroscope System received FDA 510(k) clearance on 2021-09-15, under approval number K211227.

What company makes HTx Disposable Hysteroscope System?

HTx Disposable Hysteroscope System is manufactured by Acuvu, Inc..

What is the FDA product code for HTx Disposable Hysteroscope System?

The FDA product code for HTx Disposable Hysteroscope System is HIH.

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Other Devices by Acuvu, Inc.

K180096GDT-1000 System

Related Devices (Code: HIH)

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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.

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