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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?
Product Code :
HFF
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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