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FDA 510(k)

Omni Hysteroscope, Omni Lok cervical seal

K-Number: K191281 · 2019-08-29

ApplicantHologic, Inc.
Decision Date2019-08-29
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Omni Hysteroscope, Omni Lok cervical seal is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2019-08-29 under approval number K191281. 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 Omni Hysteroscope, Omni Lok cervical seal?

Omni Hysteroscope, Omni Lok cervical seal is a medical device that received FDA 510(k) clearance on 2019-08-29. It is manufactured by Hologic, Inc.. The 510(k) number is K191281.

When was Omni Hysteroscope, Omni Lok cervical seal approved by the FDA?

Omni Hysteroscope, Omni Lok cervical seal received FDA 510(k) clearance on 2019-08-29, under approval number K191281.

What company makes Omni Hysteroscope, Omni Lok cervical seal?

Omni Hysteroscope, Omni Lok cervical seal is manufactured by Hologic, Inc..

What is the FDA product code for Omni Hysteroscope, Omni Lok cervical seal?

The FDA product code for Omni Hysteroscope, Omni Lok cervical seal 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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