Acclarent, Inc.
Acclarent, Inc. holds FDA 510(k) medical device clearances, first cleared 2005, most recent 2026, with 13 FDA device recalls on record.
Top product codes for Acclarent, Inc.
FDA recalls by Acclarent, Inc.
10 most recent of 13- Z-0127-2024 — TruDi Navigation System, Model: FG-2000-00, Catalog: ENS022B, when used with TruDi Curette, Models: TDC0005Z and TDC0005
- Z-0415-2022 — TruDi NAV Suction Instruments: 0-Degree, REF: TDNS000Z; 70-Degree, REF: TDNS070Z; and 90-Degree, REF: TDNS090Z
- Z-0824-2020 — TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
- Z-0825-2020 — TruDi NAV Suction, TDNS070Z, 70 Degree Tip Angle (01) 10705031245884
- Z-0826-2020 — TruDi NAV Suction, TDNS090Z, 90 Degree Tip Angle, (01) 10705031245891
- Z-1740-2015 — RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
- Z-1863-2013 — Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1862-2013 — Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1866-2013 — Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1864-2013 — Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Acclarent, Inc.
- K253612 — Acclarent AERA Eustachian Tube Balloon Dilation System
- K230742 — ACCLARENT AERA Eustachian Tube Dilation System
- K231862 — TruDi® Navigation System V3 (FG-2000-00)
- K221037 — TruDi Shaver Blade
- K201115 — Next Generation Balloon Dilation System
- K201174 — TruDi Curette
- K193453 — TruDi Probe
- K190525 — RELIEVA ULTIRRA Sinus Balloon Catheter
- K190532 — TruDi NAV Wire
- K183090 — Relieva Tract Balloon Dilation System
- K180948 — TruDi NAV Suction Instruments
- K173628 — Acclarent ENT Navigation System
- K171761 — ACCLARENT AERA Eustachian Tube Balloon Dilation System
- K171687 — Relieva SpinPlus Nav Balloon Sinuplasty System
- K161697 — Acclarent NavWire Sinus Navigation Guidewire
- K161698 — Relieva UltirraNav Sinus Balloon Catheter
- DEN150056 — Acclarent Aera Eustachian Tube Balloon Dilation System
- K153341 — Relieva Scout Multi-Sinus Dilation System
- K150453 — TULA Iontophoresis System with Earset
- K143541 — Relieva SpinPlus Balloon Sinuplasty System
- K150172 — ACCLARENT SE Inflation Device
- K132433 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
- K140160 — RELIEVA SCOUT SINUS DILATION SYSTEM
- K120280 — RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM
- K111875 — RELIEVA SPIN SINUS DILATION SYSTEM
- K110687 — RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL)
- K111254 — RELIEVA SOLO ELITE SINUS BALLOON CATHETER
- K110636 — TULA IONTOPHORESIS SYSTEM
- K110097 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
- K103595 — ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
- K110218 — INSPIRA AIR BALLOON DILATION SYSTEM
- K100577 — ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE
- K093594 — MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER
- K090660 — AIRWAY BALLOON CATHETER INFLATION DEVICE
- K083574 — RELIEVA STRATUS MICROFLOW SPACER
- K082188 — TYMPANOSTOMY TUBE
- K072891 — SINUS SPACER
- K073041 — RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER
- K073276 — IONTOPHORESIS SYSTEM
- K071845 — RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A
- K063078 — MICROENDOSCOPE
- K062458 — ETHMOID SINUS SPACER
- K061903 — RELIEVA SINUS BALLOON CATHETER
- K060974 — RELIENT NAVIGATION DEVICE
- K052198 — RELIEVA SINUS BALLOON INFLATION DEVICE
Data sourced from openFDA. This site is unofficial and independent of the FDA.