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FDA 510(k)

Hystero-V Hysteroscope

K-Number: K202445 · 2021-11-23

ApplicantHysterovue, Inc.
Decision Date2021-11-23
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Hystero-V Hysteroscope is a medical device manufactured by Hysterovue, Inc.. It received FDA 510(k) clearance on 2021-11-23 under approval number K202445. 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 Hystero-V Hysteroscope?

Hystero-V Hysteroscope is a medical device that received FDA 510(k) clearance on 2021-11-23. It is manufactured by Hysterovue, Inc.. The 510(k) number is K202445.

When was Hystero-V Hysteroscope approved by the FDA?

Hystero-V Hysteroscope received FDA 510(k) clearance on 2021-11-23, under approval number K202445.

What company makes Hystero-V Hysteroscope?

Hystero-V Hysteroscope is manufactured by Hysterovue, Inc..

What is the FDA product code for Hystero-V Hysteroscope?

The FDA product code for Hystero-V Hysteroscope 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.

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