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510(k) Data Aggregation
K Number
K993851Device Name
SODEM PERFORATOR DRIVE
Manufacturer
SODEMSYSTEMS
Date Cleared
1999-12-27
(45 days)
Product Code
HBB
Regulation Number
882.4370Why did this record match?
Applicant Name (Manufacturer) :
SODEMSYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sodem Perforator Drive is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patien's skull. The system is intended for use in neurosurgery.
Device Description
The Sodem Perforator Drive PN 3510 is made out of the combination of 2 components from the Sodem Power System. the Pneumatic motor currently used as part of the Sodem Power System and a Hudson Adapter. Sodem is not manufacturing "Cranial Perforator attachment". The technological characteristics of the Sodem Perforator Drive are similar to the pneumatic handpiece from the Sodem Power System. The safety device (disengagement of rotational movement of the "cranial perforator attachment"after relevant perforation of skull) is exclusively dependent of this attachment (not the motor). This safety device is functional so far the speed range is being respected. The speed range is indicated on the instructions for use of the manufacturer(s) of the "cranial perforator attachments" and our perforator drive motor is falling within recommended range of operation.
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