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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 1 of 4

Device	Model / Reference	Registries	Class	Status
Relieva Flex	GC000RF	FDA UDI	Class I	Active
TruDi Curette	TDC0005Z	FDA UDI	Class II	Active
Relieva Luma	SISLGCAWOLF	FDA UDI	Class I	Active
Relieva Spinplus	RSP0616F	FDA UDI	Class I	Active
Acclarent Se Inflation Device	SEID	FDA UDI	Class I	Active
Relieva Sidekick Lp	SDKKLP	FDA UDI	Class I	Active
Relieva Luma	SISLGCAOLYMP	FDA UDI	Class I	Active
Relieva Spin	RS0616FZ	FDA UDI	Class I	Active
Relieva Spin	RS0616M	FDA UDI	Class I	Active
TruDi Curette	TDC0005	FDA UDI	Class II	Active
TruDi Shaver Blade	TSB3STR	FDA UDI	Class II	Active
Relieva Flex	GC000RFZ	FDA UDI	Class I	Active
Relieva Vortex 2	RV02Z	FDA UDI	Class I	Active
Relieva Scout	SCT0624MFSZ	FDA UDI	Class I	Active
TruDi Probe	TDP0705	FDA UDI	Class II	Active
Relieva Flex	GC110RFZ	FDA UDI	Class I	Active
Relieva Flex	GC070CRF	FDA UDI	Class I	Active
Relieva Spinplus	RSP0516	FDA UDI	Class I	Active
Relieva Spin	RS0616MFSZ	FDA UDI	Class I	Active
Relieva Spin	RSM110	FDA UDI	Class I	Active
Relieva Spinplus	RSP0616M	FDA UDI	Class I	Active
Acclarent Aera	EU061655	FDA UDI	Class II	Active
TruDi Shaver Blade	TSB415Z	FDA UDI	Class II	Active
Relieva Spin	RSF70Z	FDA UDI	Class I	Active
Acclarent Pivot	PVT0616N	FDA UDI	Class II	Active
Relieva Tract	RT1240AZ	FDA UDI	Class I	Active
Relieva Spinplus	RSP0616MFSZ	FDA UDI	Class I	Active
TruDi NAV Suction	TDNS000Z	FDA UDI	Class II	Active
Acclarent Se Inflation Device	SEID	FDA UDI	Class I	Active
TruDi Shaver Blade	TSB460	FDA UDI	Class II	Active
TruDi Shaver Blade	TSB415	FDA UDI	Class II	Active
Relieva Spinplus	RSP0616FZ	FDA UDI	Class I	Active
Inspira Air	BC1640AZ	FDA UDI	Class II	Active
Relieva Luma Sentry	SIS100B	FDA UDI	Class I	Active
Acclarent Pivot	PVT0616Z	FDA UDI	Class II	Active
Relieva Circa	EP01	FDA UDI	Class I	Active
Inspira Air	BC8524A	FDA UDI	Class II	Active
Relieva Sidekick Lp	SDKKLPZ	FDA UDI	Class I	Active
TruDi NAV Cable	TDNC001	FDA UDI	Class II	Active
Relieva Tract	RT1640A	FDA UDI	Class I	Active
Relieva Spinplus	RSP0616Z	FDA UDI	Class I	Active
Relieva Spinplus	RSP0616	FDA UDI	Class I	Active
Inspira Air	BC1040A	FDA UDI	Class II	Active
Relieva Spin	RSM110CZ	FDA UDI	Class I	Active
Acclarent Navwire	GW35150NZ1PK	FDA UDI	Class II	Active
TruDi NAV Cable	TDNC001Z	FDA UDI	Class II	Active
Relieva Flex	GC090RFZ	FDA UDI	Class I	Active
Relieva Tract	RT1640AZ	FDA UDI	Class I	Active
TruDi NAVWIRE	TDNW001Z	FDA UDI	Class II	Active
TruDi Shaver Blade	TSB4STR	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.