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FDA 510(k)

FemVue MINI Saline-Air Device

K-Number: K242002 · 2024-11-22

ApplicantFemasys, Inc.
Decision Date2024-11-22
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FemVue MINI Saline-Air Device is a medical device manufactured by Femasys, Inc.. It received FDA 510(k) clearance on 2024-11-22 under approval number K242002. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FemVue MINI Saline-Air Device?

FemVue MINI Saline-Air Device is a medical device that received FDA 510(k) clearance on 2024-11-22. It is manufactured by Femasys, Inc.. The 510(k) number is K242002.

When was FemVue MINI Saline-Air Device approved by the FDA?

FemVue MINI Saline-Air Device received FDA 510(k) clearance on 2024-11-22, under approval number K242002.

What company makes FemVue MINI Saline-Air Device?

FemVue MINI Saline-Air Device is manufactured by Femasys, Inc..

What is the FDA product code for FemVue MINI Saline-Air Device?

The FDA product code for FemVue MINI Saline-Air Device is LKF.

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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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