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510(k) Data Aggregation
K Number
K093218Device Name
FEMEYE TWO
Manufacturer
Date Cleared
2010-05-18
(217 days)
Product Code
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
FEMSUITE, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FemEye Two™ Hysteroscope is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal Uterine Bleeding .
- Infertility and Pregnancy Wastage .
- Evaluation of Abnormal Hysterosalpingogram, ●
- Intrauterine Foreign Body .
- Amenorrhea ●
- Pelvic Pain .
Device Description
The FemEye Two™ Hysteroscope is designed as a handheld, low-voltage camera device suitable for use during both in-office as well as in-hospital diagnostic procedures. The FemEye Two is a continuous flow hysteroscope intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures.
The device consists of a hysteroscopic endoscope and is provided sterile for single patient use. It consists of a small diameter, rigid shaft and a handle. The shaft contains a camera and integrated light source as well as an irrigation/working channel port. The nondisposable portion of the FemEye Two is the battery cartridge which powers the device.
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