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510(k) K121351

SINUS DILATION SYSTEM by Entrigue Surgical, Inc. — Product Code LRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2012
Date Received
May 4, 2012
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 Entrigue Surgical, Inc.

  • K130354 — MEDIENT MIDDLE TURBINATE IMPLANT; (SINGLE PACK-1 PAIR, FOUR PACK-4 PAIR) (May 29, 2013)
  • K082750 — ENTACT SEPTAL STAPLER, MODEL 610-00100 (January 6, 2009)
  • K072470 — BIOELAST 5-0 SUTURE, MODEL 500100 (November 16, 2007)

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  • 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)