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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 3 of 4

Device	Model / Reference	Registries	Class	Status
Relieva Spin	RSS0	FDA UDI	Class I	Active
Relieva Spin	RS0516F	FDA UDI	Class I	Active
Relieva Ultirra	BC0716RU	FDA UDI	Class I	Active
Relieva Spinplus	RSP0516M	FDA UDI	Class I	Active
Acclarent Cyclops	CYE002	FDA UDI	Class II	Active
Relieva Tract	RT1440A	FDA UDI	Class I	Active
Inspira Air	BC1440AZ	FDA UDI	Class II	Active
Relieva Spinplus	RSP0516MFS	FDA UDI	Class I	Active
Relieva Tract	RT1440AZ	FDA UDI	Class I	Active
Relieva Spin	RS0516M	FDA UDI	Class I	Active
Inspira Air	BC1240A	FDA UDI	Class II	Active
Relieva Tract	RT1040A	FDA UDI	Class I	Active
TruDi Shaver Blade	TSB440	FDA UDI	Class II	Active
Relieva Flex	GC090RF	FDA UDI	Class I	Active
TruDi NAV Suction	TDNS090Z	FDA UDI	Class II	Active
Relieva Spinplus	RSP0616MFS	FDA UDI	Class I	Active
Inspira Air	BC8524AZ	FDA UDI	Class II	Active
Relieva Vortex 2	RV02	FDA UDI	Class I	Active
Relieva Ultirra	BC0724RU	FDA UDI	Class I	Active
Relieva Scout	SCT0624MFS	FDA UDI	Class I	Active
Relieva Spin	RS0516FZ	FDA UDI	Class I	Active
TruDi Shaver Blade	TSB4STRZ	FDA UDI	Class II	Active
Relieva Spin	RS0516MFSZ	FDA UDI	Class I	Active
Inspira Air	BC1040AZ	FDA UDI	Class II	Active
Relieva Spinplus	RSP0516MFSZ	FDA UDI	Class I	Active
Relieva Ultirra Nav	BC0516RUN	FDA UDI	Class I	Active
Relieva Luma Sentry	SIS100BZ	FDA UDI	Class I	Active
Tympanostomy Tube	K082188	FDA 510(k)	Class II	Active
TruDi NAV Wire	K190532	FDA 510(k)	Class II	Active
Tula Iontophoresis System	K110636	FDA 510(k)	Class II	Active
Relieva Sinus Balloon Catheter	K061903	FDA 510(k)	Class I	Active
Relient Navigation Device	K060974	FDA 510(k)	Class I	Active
Relieva Solo Elite Sinus Balloon Catheter	K111254	FDA 510(k)	Class I	Active
Relieva Sinus Balloon Inflation Device	K052198	FDA 510(k)	Class I	Active
TULA Iontophoresis System with Earset	K150453	FDA 510(k)	Class II	Active
TruDi Probe	K193453	FDA 510(k)	Class II	Active
Acclarent Cyclops Multi-Angle Endoscope	K100577	FDA 510(k)	Class II	Active
Acclarent Cyclops Multi-Angle Endoscope	K110097	FDA 510(k)	Class II	Active
Relieva UltirraNav Sinus Balloon Catheter	K161698	FDA 510(k)	Class I	Active
ACCLARENT AERA Eustachian Tube Balloon Dilation System	K171761	FDA 510(k)	Class II	Active
Acclarent ENT Navigation System	K173628	FDA 510(k)	Class II	Active
Relieva SpinPlus Nav Balloon Sinuplasty System	K171687	FDA 510(k)	Class I	Active
Modification To Relieva Stratus Microflow Spacer	K093594	FDA 510(k)	Class I	Active
ACCLARENT SE Inflation Device	K150172	FDA 510(k)	Class I	Active
Ethmoid Sinus Spacer	K062458	FDA 510(k)	Class I	Active
Relieva Stratus Microflow Spacer	K083574	FDA 510(k)	Class I	Active
Relieva Spin Sinus Dilation System	K111875	FDA 510(k)	Class I	Active
Acclarent Cyclops Multi-Angle Endoscope	K132433	FDA 510(k)	Class II	Active
Acclarent AERA Eustachian Tube Balloon Dilation System	K253612	FDA 510(k)	Class II	Active
TruDi® Navigation System V3 (FG-2000-00)	K231862	FDA 510(k)	Class II	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.