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510(k) K183090

Relieva Tract Balloon Dilation System by Acclarent, Inc. — Product Code QGK

K183090 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "Relieva Tract Balloon Dilation System". The FDA issued a decision of Substantially Equivalent on April 19, 2019. The device falls under product code QGK (Balloon, Nasal Airway), a Class I device regulated under 21 CFR 874.4420. Acclarent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2019
Date Received
November 6, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Balloon, Nasal Airway
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type

The nasal airway balloon is intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction.

Other clearances by Acclarent, Inc.

  • K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System (February 19, 2026)
  • K230742 — ACCLARENT AERA Eustachian Tube Dilation System (December 13, 2023)
  • K231862 — TruDi® Navigation System V3 (FG-2000-00) (July 21, 2023)
  • K221037 — TruDi Shaver Blade (July 20, 2022)
  • K201115 — Next Generation Balloon Dilation System (August 27, 2020)
  • K201174 — TruDi Curette (August 12, 2020)
  • K193453 — TruDi Probe (March 23, 2020)
  • K190532 — TruDi NAV Wire (May 3, 2019)
  • K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter (May 3, 2019)
  • K180948 — TruDi NAV Suction Instruments (July 20, 2018)

FDA data resources