Home / 510(k) Clearances / K120962

510(k) K120962

PATHASSIST LIGHT FIBER by Entellus Medical, Inc. — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2012
Date Received
March 30, 2012
Clearance Type
Special
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.

  • K220027 — Audion ET dilation system (April 12, 2022)
  • K163509 — XprESS ENT Dilation System (April 5, 2017)
  • K163435 — Entellus Medical Reinforced Anesthesia Needle (April 5, 2017)
  • K152435 — PassAssist LED Light Fiber (November 20, 2015)
  • 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)

Other clearances for product code LRC

  • K230258 — BB 8 Sinus Dilation Kit (May 25, 2023)
  • K212774 — VenSure LightGuide (February 4, 2022)
  • K201398 — SINUSPRIME Dilation System (October 15, 2020)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201472 — VenSure Balloon Device, VenSure Nav Balloon Device (August 26, 2020)
  • K181546 — Dillard Nasal Balloon Catheter (January 3, 2020)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • 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)