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FDA 510(k)

FEMCHEC PRESSURE MANAGEMET DEVICE

K-Number: K110993 · 2011-10-12

ApplicantFemasys, Inc.
Decision Date2011-10-12
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMCHEC PRESSURE MANAGEMET 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 2011-10-12 under 510(k) number K110993. 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 FEMCHEC PRESSURE MANAGEMET DEVICE?

FEMCHEC PRESSURE MANAGEMET DEVICE is a medical device that received FDA 510(k) clearance on 2011-10-12. The listed applicant is Femasys, Inc.. The 510(k) number is K110993.

When did FEMCHEC PRESSURE MANAGEMET DEVICE receive FDA 510(k) clearance?

FEMCHEC PRESSURE MANAGEMET DEVICE received FDA 510(k) clearance on 2011-10-12, under 510(k) number K110993.

Who is the listed applicant for FEMCHEC PRESSURE MANAGEMET 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 FEMCHEC PRESSURE MANAGEMET DEVICE?

The FDA product code for FEMCHEC PRESSURE MANAGEMET 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-009K110288FEMVUE SALINE-AIR 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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