Acclarent, Inc.

FDA Regulatory Profile

Summary

Total Recalls
13
510(k) Clearances
45
Inspections
4
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-0127-2024Class IITruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: September 21, 2023
Z-0415-2022Class IITruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REFNovember 12, 2021
Z-0826-2020Class IITruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891March 6, 2019
Z-0824-2020Class IITruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877March 6, 2019
Z-0825-2020Class IITruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884March 6, 2019
Z-1740-2015Class IIIRELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter -April 28, 2015
Z-1863-2013Class IIInspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tJanuary 11, 2013
Z-1865-2013Class IIInspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tJanuary 11, 2013
Z-1860-2013Class IIInspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tJanuary 11, 2013
Z-1861-2013Class IIInspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tJanuary 11, 2013
Z-1866-2013Class IIInspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tJanuary 11, 2013
Z-1864-2013Class IIInspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tJanuary 11, 2013
Z-1862-2013Class IIInspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway January 11, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemFebruary 19, 2026
K230742ACCLARENT AERA Eustachian Tube Dilation SystemDecember 13, 2023
K231862TruDi® Navigation System V3 (FG-2000-00)July 21, 2023
K221037TruDi Shaver BladeJuly 20, 2022
K201115Next Generation Balloon Dilation SystemAugust 27, 2020
K201174TruDi CuretteAugust 12, 2020
K193453TruDi ProbeMarch 23, 2020
K190525RELIEVA ULTIRRA Sinus Balloon CatheterMay 3, 2019
K190532TruDi NAV WireMay 3, 2019
K183090Relieva Tract Balloon Dilation SystemApril 19, 2019
K180948TruDi NAV Suction InstrumentsJuly 20, 2018
K173628Acclarent ENT Navigation SystemMarch 10, 2018
K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemJanuary 16, 2018
K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemSeptember 5, 2017
K161697Acclarent NavWire Sinus Navigation GuidewireOctober 24, 2016
K161698Relieva UltirraNav Sinus Balloon CatheterOctober 24, 2016
DEN150056Acclarent Aera Eustachian Tube Balloon Dilation SystemSeptember 16, 2016
K153341Relieva Scout Multi-Sinus Dilation SystemFebruary 12, 2016
K150453TULA Iontophoresis System with EarsetMay 20, 2015
K143541Relieva SpinPlus Balloon Sinuplasty SystemApril 22, 2015