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510(k) Data Aggregation
K Number
K070509Device Name
FISSO HOLDING SYSTEM
Manufacturer
BAITELLA AG
Date Cleared
2007-03-22
(28 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
BAITELLA AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FISSO Holding System consists of a table-mounted endoscope holder system intended for use by surgeons to hold endoscopes and arthroscopes with a diameter of 4mm to 10mm during general diagnostic and therapeutic procedures. The device is also intended for use by qualified surgeons for holding endoscopes during diagnostic and therapeutic neurologic procedures
Device Description
Table-mounted self-retaining endoscope holder system consisting of stainless steel tubular, articulated arms that are connected to a vertical stand and are freely adjustable within the articulating radius according to the requirements of the particular surgical procedure. All joints are locked in position simultaneously via the adjustment knob located on the central joint. Accessories include endoscope holders for 4mm to 10mm scopes as well as multiple class-l holding devices. The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
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