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510(k) K163435

Entellus Medical Reinforced Anesthesia Needle by Entellus Medical, Inc. — Product Code BSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2017
Date Received
December 7, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Device Class
Class II
Regulation Number
868.5150
Review Panel
AN
Submission Type

Other clearances by Entellus Medical, Inc.

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  • K152434 — XprESS Multi-Sinus Dilation System (November 20, 2015)
  • K142252 — XprESS Multi-Sinus Dilation Tool (October 17, 2014)
  • K141916 — PATHASSIST LED LIGHT FIBER (August 7, 2014)
  • K133563 — PATHASSIST LIGHT SEEKER (December 20, 2013)
  • K132440 — XPRESS MULTI-SINUS DILATION TOOL (October 4, 2013)
  • K130503 — PATHASSIST LED LIGHT FIBER (June 11, 2013)
  • K121943 — XPRESS MULTI-SINUS DILATION TOOL (August 22, 2012)

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