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510(k) Data Aggregation
K Number
K242002Device Name
FemVue MINI Saline-Air Device
Manufacturer
Femasys Inc.
Date Cleared
2024-11-22
(136 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Femasys Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FemVue MINI is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
Device Description
Fem Vue® MINI is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterilization and is intended for single-use.
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K Number
K241693Device Name
FemChec Controlled Saline-Air Device (FCD-250)
Manufacturer
Femasys Inc.
Date Cleared
2024-09-06
(86 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
Femasys Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FemChec® is intended to instill a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
Device Description
FemChec® is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter for controlled delivery of saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity. The device operates by retraction of the plunger, which simultaneously fills the two syringes in the device with either air or saline. The device is then connected to a compatible uterine catheter, and when the plunger is depressed, a consistent stream of saline and air is delivered into the uterus and fallopian tubes. The device is provided sterile via EO sterilization and is intended for single-use.
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K Number
K231730Device Name
FemaSeed Intratubal Insemination
Manufacturer
Femasys Inc.
Date Cleared
2023-09-22
(101 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
Femasys Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemaSeed Intratubal Insemination is intended to introduce washed sperm or in vitro fertilized (IVF) embryos into the uterine ostium via ultrasound guidance
Device Description
The FemaSeed Intratubal Insemination consists of polymer curved transfer catheter with balloon, polymer guide catheter and separate balloon inflation syringe. The balloon inflation syringe is a 3 mL syringe fitted with clips that allow for the piston to lock in place to maintain balloon inflation. When the clips are pinched, the piston releases, deflating the balloon. The device is intended to deliver washed sperm or in vitro fertilized embryos into the uterine ostium via ultrasound guidance by a licensed healthcare provider specifically trained in women's health.
Prior to insertion, the slider is moved back until the curved transfer catheter is fully retracted and contained within guide catheter. The preassembled guide catheter is then passed transvaginally through the cervix to the fundus, under ultrasound guidance. Once in position, the preloaded transfer catheter is advanced approximately 2 cm into the uterine ostium and the balloon is inflated with the provided syringe. The balloon location in the uterine ostium is confirmed using ultrasound. The samples are then instilled into the uterine ostium of the fallopian tube, followed by deflating the balloon and discarding the device. The recommended volume for loading washed sperm should not exceed 1 mL and 50-100 µL when loading embryos.
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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?
Applicant Name (Manufacturer) :
FEMASYS INC.
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
K110993Device Name
FEMCHEC PRESSURE MANAGEMET DEVICE
Manufacturer
FEMASYS INC.
Date Cleared
2011-10-12
(187 days)
Product Code
LKF, CLA
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
FEMASYS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemChec™ Pressure Management Device limits the maximum applied pressure while instilling contrast media into the uterus and fallopian tubes. It is to be used in conjunction with an intrauterine catheter for performance of hysterosalpingogram (HSG), such as tubal occlusion confirmation tests in women who have had tubal procedures for permanent female sterilization. The FemChec limits the applied intrauterine pressure to 200 mmHg.
The FemChec is provided with a fluid collector, stopcock, and intrauterine catheter for performing the HSG procedure.
Device Description
The FemChec Pressure Management Device (FemChec) is a pressure-limiting contrast media syringe that is connected to an intrauterine catheter for low-pressure instillation of contrast media during HSG procedures.
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K Number
K110288Device Name
FEMVUE SALINE-AIR DEVICE
Manufacturer
FEMASYS INC.
Date Cleared
2011-04-28
(86 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
FEMASYS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemVue™ Saline-Air Device instills a consistent alternating pattern of saline and air as a continuous stream of contrast media into the uterus and fallopian tubes to be used in conjunction with an intrauterine catheter for performance of sono-hysterosalpingogram (Sono HSG).
Device Description
The FemVue™ Saline-Air Device is a dual-barrel contrast media syringe that can be connected to an intrauterine catheter to instill saline-air contrast media during sono-hysterosalpingogram (Sono HSG) procedures. Sono HSG consists of an ultrasound evaluation of the fallopian tubes with or without assessment of the uterine cavity.
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K Number
K100662Device Name
FEMVUE CORNUAL BALLOON CATHETER
Manufacturer
FEMASYS INC.
Date Cleared
2010-04-07
(30 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
FEMASYS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemVue™ Cornual Balloon Catheter is intended for the delivery of contrast media during hysterosalpingogram (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
Device Description
The FemVue Cornual Balloon Catheter ("FCBC") is a latex-free Balloon Catheter within a transcervical Delivery Sheath.
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K Number
K083690Device Name
FEMVUE(TM) CATHETER SYSTEM
Manufacturer
FEMASYS INC.
Date Cleared
2009-06-23
(193 days)
Product Code
LKF
Regulation Number
884.4530Why did this record match?
Applicant Name (Manufacturer) :
FEMASYS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FemVue™ Catheter System is intended for the delivery of contrast media during hysterosalpingography (HSG) and saline infusion hysterosonography (SIS) for the evaluation of the fallopian tube(s) selectively and/or the uterus. The following are some clinical indications: suspected polyps, fibroids, adhesions, or endometrial thickening, and/or the selective evaluation of fallopian tube patency.
Device Description
The FemVue Catheter System ("FCS") is comprised of two components: a Sheath and a latex free balloon Catheter. The Sheath is used to deliver the Catheter into the uterus.
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