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510(k) Data Aggregation
K Number
K123151Device Name
ENDOSEE MODEL 8000 U-SCOPE
Manufacturer
ENDOSEE CORP
Date Cleared
2013-03-08
(150 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
ENDOSEE CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The U-Scope device 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 bleeding; infertility and pregnancy wastage; evaluation of abnormal hysterosalpingogram; intrauterine foreign body; amenorrhea; and pelvic pain.
Device Description
The EndoSee U-Scope Model 8000 is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable hysteroscopic cannula and a reusable handle. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at the tip and a channel for infusion of irrigating fluid. The disposable cannula is sterilized and packaged in a sealed bag. The handle is light weight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the cannula. The handle contains the remaining electronics including a power on/off button, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers and firmware.
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