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510(k) Data Aggregation
K Number
K071756Device Name
ENDOHUB- 1.0 ENDOSCOPIC VIDEO CAMERA SYSTEM WITH VIDEO CAPTURE
Manufacturer
POINTE CONCEPTION MEDICAL, INC
Date Cleared
2007-08-15
(48 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
POINTE CONCEPTION MEDICAL, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endohub-1.0 Endoscopic Video Camera with Video Capture is intended to be used as an endoscopic video camera in a variety of endoscopic surgical procedures, including but not limited to; orthopedic, laparoscopic, urologic, sinuscopic and plastic surgical procedures. The device is also intended to be used as an accessory for microscopic surgery.
Device Description
The Endohub-1.0 Endoscopic Video Camera System is a video camera system which consists of a Camera Control Unit [CCU] and Camera Head. The Endohub-1.0 Camera System is used in conjunction with an endoscope to allow for visualization during minimally invasive surgical procedures. Sterilization of the camera head may be required prior to use. The camera head may be steam sterilized. The camera head may utilize 1CCD or 3CCD image sensors, and employ either fixed or variable focal length optics. The Endohub-1.0 Camera System incorporates an image capture system which allows for the capture of streaming video or still video images.
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