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FDA 510(k)

FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009

K-Number: K122658 · 2012-12-20

ApplicantFemasys, Inc.
Decision Date2012-12-20
Product CodePCF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 is the device name listed in this FDA 510(k) record. The listed applicant is Femasys, Inc.. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K122658. The device is classified under product code PCF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009?

FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Femasys, Inc.. The 510(k) number is K122658.

When did FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 receive FDA 510(k) clearance?

FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 received FDA 510(k) clearance on 2012-12-20, under 510(k) number K122658.

Who is the listed applicant for FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009?

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 FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009?

The FDA product code for FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 is PCF.

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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 InseminationK110993FEMCHEC PRESSURE MANAGEMET DEVICEK110288FEMVUE SALINE-AIR DEVICE

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Related Devices (Code: PCF)

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.

K060320FEMECC ENDOCERVICAL CURETTEFemspec LLCK882606EURO-MED ENDO-CURETTEBuckman Co., Inc.K882404KEVOR-CURETTEEuro-Med Intl.K860796DISPO-URETTERoland J. Zwick, 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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