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510(k) Data Aggregation
K Number
K170708Device Name
OWL RF INSULATED CANNULAE
Manufacturer
Date Cleared
2017-06-27
(111 days)
Product Code
Regulation Number
882.4725Why did this record match?
Applicant Name (Manufacturer) :
Diros Technology Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Diros OWL RF Insulated Cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.
Device Description
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