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510(k) K152435

PassAssist LED Light Fiber by Entellus Medical, Inc. — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2015
Date Received
August 27, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ent Manual Surgical
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

Other clearances by Entellus Medical, Inc.

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  • K163435 — Entellus Medical Reinforced Anesthesia Needle (April 5, 2017)
  • 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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  • K181838 — Sinusway Dilation System (December 20, 2018)
  • K172737 — MESIRE - Balloon Sinus Dilatation System (December 12, 2017)
  • K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System (September 5, 2017)