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510(k) Data Aggregation
K Number
K082841Device Name
SPINAL FORAMINOSCOPE
Manufacturer
BLAZEJEWSKI MEDI-TECH GMBH
Date Cleared
2009-09-09
(348 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
BLAZEJEWSKI MEDI-TECH GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spinal Foraminoscope for lumbar access is indicated for endoscopic visualization in the lumbar region. The Spinal Foraminoscope for cervical access is indicated for visual inspection of the cervical spinal nerve roots and surrounding tissue.
Device Description
The Spinal Foraminoscope for lumbar access is an optical and fiberoptic-based rigid endoscope provided with a 2.8 or 3.7 mm working channel and two 1.5-mm irrigation channels and allowing insertion of 2.8-mm or 3.5-mm hand-held instruments. The Spinal Foraminoscope for cervical access is a fiberoptic-based rigid endoscope which shares the same design. It is provided with a 2.2-mm working and irrigation channel, has a 3.6- mm outer diameter and allows insertion of 2.0-mm hand-held instruments. The Spinal Foraminoscope may be attached to standard fiberoptic light sources and Storz, Olympus, Wolf and ACM cameras and video adapters.
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