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510(k) K092973

DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE by Bionen S.A.S. — Product Code IKT

K092973 is an FDA 510(k) premarket notification submitted by Bionen S.A.S. for the device "DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE". The FDA issued a decision of Substantially Equivalent on October 7, 2010. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2010
Date Received
September 25, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

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FDA data resources