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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 2 of 4

Device	Model / Reference	Registries	Class	Status
Relieva Spin	RS0516MFS	FDA UDI	Class I	Active
Relieva Spin	RS0516MZ	FDA UDI	Class I	Active
Relieva Spin	RSF70	FDA UDI	Class I	Active
Relieva Spin	RS0616MFS	FDA UDI	Class I	Active
Relieva Flex	GC070CRFZ	FDA UDI	Class I	Active
Relieva Spinplus Nav	RSP0516MFSN	FDA UDI	Class I	Active
Relieva Tract	RT1240A	FDA UDI	Class I	Active
Acclarent Cyclops	CYE002R	FDA UDI	Class II	Active
Inspira Air	BC1440A	FDA UDI	Class II	Active
Inspira Air	BC0724A	FDA UDI	Class II	Active
Inspira Air	BC0724AZ	FDA UDI	Class II	Active
Relieva Spinplus	RSP0516Z	FDA UDI	Class I	Active
Relieva Spin	RSM110Z	FDA UDI	Class I	Active
Relieva Luma	SISLGC208	FDA UDI	Class I	Active
TruDi Probe	TDP0005Z	FDA UDI	Class II	Active
Relieva Spin	RSS0Z	FDA UDI	Class I	Active
Relieva Ultirra	BC0516RU	FDA UDI	Class I	Active
TruDi Shaver Blade	TSB460Z	FDA UDI	Class II	Active
Relieva Spin	RSM110C	FDA UDI	Class I	Active
Relieva Luma	SISLGCASTORZ	FDA UDI	Class I	Active
Relieva Spinplus	RSP0516MZ	FDA UDI	Class I	Active
Relieva Flex	GC110RF	FDA UDI	Class I	Active
Relieva Tract	RT1040AZ	FDA UDI	Class I	Active
TruDi NAVWIRE	TDNW001	FDA UDI	Class II	Active
Inspira Air	BC0524AZ	FDA UDI	Class II	Active
Relieva Spinplus	RSP0516FZ	FDA UDI	Class I	Active
Relieva Spin	RS0616F	FDA UDI	Class I	Active
Relieva Spinplus	RSP0616MZ	FDA UDI	Class I	Active
Acclarent Pivot	PVT0616NZ	FDA UDI	Class II	Active
Acclarent Pivot	PVT0616L	FDA UDI	Class II	Active
TruDi NAV Suction	TDNS070Z	FDA UDI	Class II	Active
Acclarent Aera	EU061655Z	FDA UDI	Class II	Active
Relieva Luma	SISLGCAACMI	FDA UDI	Class I	Active
Relieva Spinplus Nav	RSP0616MFSNZ	FDA UDI	Class II	Active
Acclarent Balloon Inflation Device	BID30	FDA UDI	Class I	Active
Relieva Ultirra	BC0616RU	FDA UDI	Class I	Active
Acclarent Pivot	PVT0616	FDA UDI	Class I	Active
Inspira Air	BC1640A	FDA UDI	Class II	Active
Inspira Air	BC0524A	FDA UDI	Class II	Active
Relieva Spin	RS0616MZ	FDA UDI	Class I	Active
Acclarent Navwire	GW35150NZ	FDA UDI	Class II	Active
TruDi Shaver Blade	TSB440Z	FDA UDI	Class II	Active
Relieva Spinplus Nav	RSP0616MFSN	FDA UDI	Class I	Active
TruDi Probe	TDP0005	FDA UDI	Class II	Active
Relieva Spinplus	RSP0516F	FDA UDI	Class I	Active
TruDi Shaver Blade	TSB3STRZ	FDA UDI	Class II	Active
TruDi Probe	TDP0705Z	FDA UDI	Class II	Active
Relieva Spinplus Nav	RSP0516MFSNZ	FDA UDI	Class II	Active
Acclarent Pivot	PVT0616LZ	FDA UDI	Class I	Active
Inspira Air	BC1240AZ	FDA UDI	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.