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510(k) Data Aggregation
K Number
K122658Device Name
FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009
Manufacturer
FEMASYS INC.
Date Cleared
2012-12-20
(111 days)
Product Code
PCF
Regulation Number
884.1050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Femasys FemCerv is a sterile, disposable endocervical sampler indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis. Clinical indications include: further evaluation of an abnormal Pap smear; cervical lesions extending into the endocervical canal; undiagnosed uterine bleeding.
Device Description
The FemCerv Endocervical Sampler (FemCerv) is a sterile, disposable device that collects an endocervical tissue sample for histological evaluation.
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K Number
K060320Device Name
FEMECC ENDOCERVICAL CURETTE
Manufacturer
FEMSPEC L.L.C.
Date Cleared
2006-07-28
(170 days)
Product Code
PCF
Regulation Number
884.1050Why did this record match?
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Matched: '884.1050'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette indicated for single patient use in obtaining tissue samples from the endocervical canal for histological analysis.
Device Description
FemSpec, LLC, FemECC™ Endocervical Curette is a sterile, disposable curette.
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K Number
K974032Device Name
ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR
Manufacturer
A & A MEDICAL, INC.
Date Cleared
1997-12-22
(60 days)
Product Code
HFC
Regulation Number
884.1050Why did this record match?
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Matched: '884.1050'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically
Device Description
The Rocket Mucus Sampler is designed for optimum suction for the collection of cervical mucosal lining, post coital test (Huhner), external os or vaginal pool sampling. It is comprised of 3 components: Plunger, O-ring and external tubing. Suction is created by pulling the plunger with a handle outward. It has a small OD of 2.6mm, which minimizes pain and discomfort to the patient. The Rocket Mucous Sampler enables the Ob/Gyn physician to collect the specimen and send it to the laboratory to be examined histologically or cytologically
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