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510(k) Data Aggregation
K Number
K163435Device Name
Entellus Medical Reinforced Anesthesia Needle
Manufacturer
Entellus Medical Inc.
Date Cleared
2017-04-05
(119 days)
Product Code
BSP
Regulation Number
868.5150Why did this record match?
Applicant Name (Manufacturer) :
Entellus Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use in injecting local anesthetics into a patient to provide regional anesthesia.
Device Description
The Entellus Medical Reinforced Anesthesia Needle is a 3.5" long disposable medical device that allows the user to transnasally administer anesthetic solutions. The Reinforced Anesthesia Needle device is a 27 gauge needle with a reinforcing sleeve which supports the needle to reduce needle flex during administration of anesthetic solutions. A slight bend at the distal end of the needle is designed to improve access to nasal anatomy. The Quincke tip extends approximately 2 mm past the reinforcing sleeve creating a distal stop. The needle hub features a standard luerlock connector.
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