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510(k) Data Aggregation
K Number
K041237Device Name
ECHOSAMPLER
Manufacturer
GYNETICS MEDICAL PRODUCTS NV
Date Cleared
2004-09-08
(120 days)
Product Code
HFF
Regulation Number
884.1060Why did this record match?
Applicant Name (Manufacturer) :
GYNETICS MEDICAL PRODUCTS NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EchoSampler™ is a single-use, sterile, disposable curette for:
- Detection of abnormalities of the uterus and endometrium using real-time sonography during injection of sterile saline into the uterine cavity
- Obtaining histological biopsy of the glandular epithelium and superficial uterine endometrial wall or sample extraction of uterine menstrual content for any of the following:
- a) Routine screening for early detection of endometrial carcinoma or other precancerous conditions which could make estrogen therapy inadvisable,
- b) Evaluation of endometrial tissue response in patients receiving estrogen replacement therapy for menopausal symptoms
- c) Endometrial dating and evaluation of uterine pathology associated with infertility, luteal insufficiency, or functional metrorrhagia
- d) Identification of specific uterine pathogens by bacterial culturing of uterine samples
- e) Inadequate imaging of the endometrium by endovaginal sonography
- f) Further evaluation of suspected abnormalities as seen on endovaginal sonography, including focal or diffuse endometrial thickening or debris,
- q) Preoperative and postoperative evaluation of the uterine cavity especially with regard to uterine polyps, myomas and cysts
- h) Congenital abnormalities and/or anatomic variants of the uterine cavity
- i) Infertility and habitual abortion
Device Description
The EchoSampler™ is a single-use, sterile, disposable curette.
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K Number
K013501Device Name
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B
Manufacturer
GYNETICS MEDICAL PRODUCTS NV
Date Cleared
2001-11-30
(39 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
GYNETICS MEDICAL PRODUCTS NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures utilizing washed spermatozoa.
The Intra-Uterine Insemination Cannula is to be used for intra uterine artificial insemination procedures and for transcervical GIFT as an introducer.
Device Description
Not Found
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K Number
K013536Device Name
EMTRAC; DELPHIN; SEMTRAC 2000 SET
Manufacturer
GYNETICS MEDICAL PRODUCTS NV
Date Cleared
2001-11-30
(38 days)
Product Code
MQF
Regulation Number
884.6110Why did this record match?
Applicant Name (Manufacturer) :
GYNETICS MEDICAL PRODUCTS NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Delphin is to be used for embryo transfer and intra uterine insemination procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
Emtrac Catheters are to be used for embryo transfer procedures for in vitro fertilization (IVF) and related assisted reproduction technology (ART) procedures.
Semtrac Sets are to be used for embryo transfer procedures for in Semilac Sets are to be acount. In the substition technology (ART) procedures.
Device Description
Not Found
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K Number
K013497Device Name
FAS SET #4551
Manufacturer
GYNETICS MEDICAL PRODUCTS NV
Date Cleared
2001-11-09
(18 days)
Product Code
MQE
Regulation Number
884.6100Why did this record match?
Applicant Name (Manufacturer) :
GYNETICS MEDICAL PRODUCTS NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A follicle aspiration set used for transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Device Description
Not Found
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