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FDA 510(k)

FEMVUE SALINE-AIR DEVICE

K-Number: K110288 · 2011-04-28

ApplicantFemasys, Inc.
Decision Date2011-04-28
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMVUE 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 2011-04-28 under 510(k) number K110288. 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 SALINE-AIR DEVICE?

FEMVUE SALINE-AIR DEVICE is a medical device that received FDA 510(k) clearance on 2011-04-28. The listed applicant is Femasys, Inc.. The 510(k) number is K110288.

When did FEMVUE SALINE-AIR DEVICE receive FDA 510(k) clearance?

FEMVUE SALINE-AIR DEVICE received FDA 510(k) clearance on 2011-04-28, under 510(k) number K110288.

Who is the listed applicant for FEMVUE 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 SALINE-AIR DEVICE?

The FDA product code for FEMVUE SALINE-AIR DEVICE is LKF.

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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)K242002FemVue MINI Saline-Air DeviceK241693FemChec Controlled Saline-Air Device (FCD-250)K231730FemaSeed Intratubal InseminationK122658FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009K110993FEMCHEC PRESSURE MANAGEMET DEVICE

View all 9 devices →

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.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.

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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