Home / 510(k) Clearances / K172737

510(k) K172737

MESIRE - Balloon Sinus Dilatation System by M/S. Meril Life Sciences Private Limited — Product Code LRC

K172737 is an FDA 510(k) premarket notification submitted by M/S. Meril Life Sciences Private Limited for the device "MESIRE - Balloon Sinus Dilatation System". The FDA issued a decision of Substantially Equivalent on December 12, 2017. The device falls under product code LRC (Instrument, Ent Manual Surgical), a Class I device regulated under 21 CFR 874.4420.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2017
Date Received
September 11, 2017
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 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)
  • K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System (September 5, 2017)
  • K161698 — Relieva UltirraNav Sinus Balloon Catheter (October 24, 2016)

FDA data resources