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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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K191281.

When did Omni Hysteroscope, Omni Lok cervical seal receive FDA 510(k) clearance?

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

Who is the listed applicant for Omni Hysteroscope, Omni Lok cervical seal?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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