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510(k) Data Aggregation
K Number
K132384Device Name
U-SCOPE 8000 SYSTEM WITH HSC+EMB CANNULA
Manufacturer
ENDOSEC CORPORATION
Date Cleared
2014-07-02
(336 days)
Product Code
HIH
Regulation Number
884.1690Why did this record match?
Applicant Name (Manufacturer) :
ENDOSEC CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The U-Scope 8000 HSC+EMB Cannula is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures and to obtain an endometrial tissue sample (biopsy) in an outpatient or office setting. The sample is used for cytologic and histologic diagnosis. 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 U-Scope 8000 HSC+EMB Cannula is a handheld, battery-operated portable hysteroscope. It includes a sterile single use disposable endometrial biopsy cannula (the U-Scope 8000 HSC+EMB cannula) and a reusable HandTower (U-Scope 8000). The disposable U-Scope 8000 HSC+EMB cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and two channels for infusion of irrigating fluid and aspiration of tissue. Adjacent to the tip of the cannula is a curette that facilitates collection of tissue during the biopsy procedure. The disposable cannula is sterilized and packaged in a sealed pouch. The HandTower is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the U-Scope 8000 HSC+EMB cannula. The HandTower contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or start/stop a video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
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