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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 the device name listed in this FDA 510(k) record. The listed applicant is Femasys, Inc.. It received FDA 510(k) clearance on 2024-11-22 under 510(k) 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. The listed applicant is Femasys, Inc.. The 510(k) number is K242002.

When did FemVue MINI Saline-Air Device receive FDA 510(k) clearance?

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

Who is the listed applicant for FemVue MINI Saline-Air Device?

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

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

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

Other records listing Femasys, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253403FemVue® Controlled Saline-Air Device (FSA-300)K241693FemChec Controlled Saline-Air Device (FCD-250)K231730FemaSeed Intratubal Insemination

Related Devices (Code: LKF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.K223064ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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