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FDA 510(k)

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths

K-Number: K182006 · 2018-12-06

ApplicantHologic, Inc.
Decision Date2018-12-06
Product CodeHIH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2018-12-06 under approval number K182006. 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 Hysteroscope Kits, Omni Sheaths?

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths is a medical device that received FDA 510(k) clearance on 2018-12-06. It is manufactured by Hologic, Inc.. The 510(k) number is K182006.

When was Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths approved by the FDA?

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths received FDA 510(k) clearance on 2018-12-06, under approval number K182006.

What company makes Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths?

Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths is manufactured by Hologic, Inc..

What is the FDA product code for Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths?

The FDA product code for Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths 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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