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ACCLARENT, INC.

Last updated September 17, 2026

Information

Country: US
Address: 7585 Irvine Center Dr, Irvine, CA, 92618
Website: integralife.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)654-2873
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3005172759
DUNS Number: 361092450

Catalogue (172)

Page 4 of 4

Device	Model / Reference	Registries	Class	Status
Relieva And Relieva Acella Sinus Balloon Catheter	K073041	FDA 510(k)	Class I	Active
Next Generation Balloon Dilation System	K201115	FDA 510(k)	Class I	Active
Inspira Air Balloon Dilation System	K110218	FDA 510(k)	Class II	Active
Airway Balloon Catheter Inflation Device	K090660	FDA 510(k)	Class II	Active
Relieva Seeker Balloon Sinuplasty System	K120280	FDA 510(k)	Class I	Active
Acclarent NavWire Sinus Navigation Guidewire	K161697	FDA 510(k)	Class II	Active
ACCLARENT AERA Eustachian Tube Dilation System	K230742	FDA 510(k)	Class II	Active
Relieva Tract Balloon Dilation System	K183090	FDA 510(k)	Class I	Active
Sinus Spacer	K072891	FDA 510(k)	Class I	Active
Relieva Stratus Pro Microflow Spacer (frontal)	K110687	FDA 510(k)	Class I	Active
Iontophoresis System	K073276	FDA 510(k)	Class II	Active
Relieva Scout Sinus Dilation System	K140160	FDA 510(k)	Class I	Active
RELIEVA ULTIRRA Sinus Balloon Catheter	K190525	FDA 510(k)	Class I	Active
Relieva Luma Sinus Illumination System, Model Sis-100a	K071845	FDA 510(k)	Class I	Active
Microendoscope	K063078	FDA 510(k)	Class II	Active
TruDi NAV Suction Instruments	K180948	FDA 510(k)	Class II	Active
TruDi Curette	K201174	FDA 510(k)	Class II	Active
Acclarent Aera Eustachian Tube Balloon Dilation System	DEN150056	FDA 510(k)	Class II	Active
TruDi Shaver Blade	K221037	FDA 510(k)	Class II	Active
Relieva Scout Multi-Sinus Dilation System	K153341	FDA 510(k)	Class I	Active
Acclarent Tympanostomy Tube And Tympanostomy Tube Delivery System	K103595	FDA 510(k)	Class II	Active
Relieva SpinPlus Balloon Sinuplasty System	K143541	FDA 510(k)	Class I	Active

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FDA Recalls (15)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 21, 2023	Z-0127-2024	—	open, classified	When using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation systems intended for use during surgical procedures of the Ear Nose and Throat (ENT) and ENT skull base surgery, which may cause delayed/prolonged surgery, cerebrospinal fluid leak, visual impairment, or skull base structural damage.
Nov 12, 2021	Z-0415-2022	—	open, classified	Suction Instruments were incorrectly calibrated so they may not meet the system accuracy specification for visual verification of device location in the patient anatomy. If the surgeon does not detect the accuracy error, this could lead to an intraprocedural delay, a potential for reversible tissue damage or damage to the carotid artery, CSF leak, or damage to optic nerve.
Mar 6, 2019	Z-0824-2020	—	terminated	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Mar 6, 2019	Z-0825-2020	—	terminated	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Mar 6, 2019	Z-0826-2020	—	terminated	The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
Apr 28, 2015	Z-1740-2015	—	terminated	Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Jan 11, 2013	Z-1865-2013	—	terminated	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Jan 11, 2013	Z-1863-2013	—	terminated	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Jan 11, 2013	Z-1860-2013	—	terminated	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Jan 11, 2013	Z-1862-2013	—	terminated	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Jan 11, 2013	Z-1861-2013	—	terminated	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Jan 11, 2013	Z-1866-2013	—	terminated	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Jan 11, 2013	Z-1864-2013	—	terminated	Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.
Jan 30, 2012	Z-1095-2012	—	terminated	Acclarent received reports of difficulty deflating the balloon during the procedure, which could potentially result in airway obstruction.
Jan 20, 2006	Z-0559-06	—	terminated	Device sterility may be compromised as evidenced by a loss of package integrity.