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510(k) Data Aggregation
K Number
K113662Device Name
FENESTRATED NERVE BLOCK NEEDLE
Manufacturer
IMD INC
Date Cleared
2012-04-20
(135 days)
Product Code
CAZ
Regulation Number
868.5140Why did this record match?
Applicant Name (Manufacturer) :
IMD INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMD's New Fenestrated Nerve Block Needle is a single patient use needle to provide local or regional nerve blocking by the injecting of a local anesthesia. It is to be used only under the direction of a licensed clinician.
Device Description
The IMD Inc. Fenestrated Nerve Block Needle shares major similarities with the predicate device(s), inasmuch as the configuration, materials, use, labeling and safety issues remain basically unchanged to the IMD predicates. It consists of a plastic hub, and a stainless steel cannula. It has the same pencil point and same side outlet (only more). The addition of fenestrations is similar to predicate anesthesia catheters. The IMD New Fenestrated Peripheral Nerve Block Needle is an anesthetic needle for peripheral nerve blocks using a local anesthetic solution. The distinct advantage offered by IMD's Fenestrated Peripheral Nerve Block Needle is due to the fenestrations. These eliminate the critical locating of the desired nerve to be blocked and only require that the needle be located in the general area for effective use.
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