This page includes the latest FDA filings for Acclarent Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3005172759 |
| FEI Number | 3005172759 |
| Name | ACCLARENT, INC. |
| Owner & Operator | ACCLARENT, INC. |
| Contact Address | 33 TECHNOLOGY DRIVE -- Irvine CA 92618 US |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 31 Technology Dr Suite 200 Irvine, CA 92618 US |
| Establishment Type | Develop Specifications But Do Not Manufacture At This Facility |
Device Company | Device | Date |
|---|---|---|
| ACCLARENT, INC. | TruDi NAV Suction TDNS090Z | 2024-11-21 |
| ACCLARENT, INC. | TruDi NAV Suction TDNS070Z | 2024-11-21 |
| ACCLARENT, INC. | TruDi NAV Suction TDNS000Z | 2024-11-21 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB460Z | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB415 | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB415Z | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB440 | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB440Z | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB3STRZ | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB3STR | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB4STR | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB4STRZ | 2022-09-19 |
| ACCLARENT, INC. | TruDi Shaver Blade TSB460 | 2022-09-19 |
Acclarent, Inc. | TruDi Shaver Blade | 2022-07-20 |
| ACCLARENT, INC. | ACCLARENT PIVOT PVT0616Z | 2020-10-09 |
| ACCLARENT, INC. | ACCLARENT PIVOT PVT0616NZ | 2020-10-09 |
| ACCLARENT, INC. | ACCLARENT PIVOT PVT0616N | 2020-10-09 |
| ACCLARENT, INC. | ACCLARENT PIVOT PVT0616LZ | 2020-10-09 |
| ACCLARENT, INC. | ACCLARENT PIVOT PVT0616L | 2020-10-09 |
| ACCLARENT, INC. | ACCLARENT PIVOT PVT0616 | 2020-10-09 |
| ACCLARENT, INC. | TruDi Curette TDC0005Z | 2020-09-08 |
| ACCLARENT, INC. | TruDi Curette TDC0005 | 2020-09-08 |
Acclarent Inc. | Next Generation Balloon Dilation System | 2020-08-27 |
Acclarent, Inc. | TruDi Curette | 2020-08-12 |
| ACCLARENT, INC. | TruDi Probe TDP0705Z | 2020-08-10 |
| ACCLARENT, INC. | TruDi Probe TDP0005Z | 2020-08-10 |
| ACCLARENT, INC. | TruDi Probe TDP0705 | 2020-08-10 |
| ACCLARENT, INC. | TruDi Probe TDP0005 | 2020-08-10 |
| ACCLARENT, INC. | ACCLARENT SE INFLATION DEVICE SEID | 2020-05-06 |
| ACCLARENT, INC. | ACCLARENT BALLOON INFLATION DEVICE BID30 | 2020-05-06 |
| ACCLARENT, INC. | ACCLARENT SE INFLATION DEVICE SEID | 2020-05-06 |
Acclarent, Inc. | TruDi Probe | 2020-03-23 |
| ACCLARENT, INC. | TruDi NAV Suction TDNS090Z | 2020-01-22 |
| ACCLARENT, INC. | TruDi NAV Suction TDNS070Z | 2020-01-22 |
| ACCLARENT, INC. | TruDi NAV Suction TDNS000Z | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1640AZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1640A | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1440AZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1440A | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1240AZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1240A | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1040AZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA TRACT RT1040A | 2020-01-22 |
| ACCLARENT, INC. | TruDi NAVWIRE TDNW001Z | 2020-01-22 |
| ACCLARENT, INC. | TruDi NAVWIRE TDNW001 | 2020-01-22 |
| ACCLARENT, INC. | TruDi NAV Cable TDNC001 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS NAV RSP0616MFSN | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS NAV RSP0516MFSN | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA ULTIRRA NAV BC0516RUN | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SCOUT SCT0624MFS | 2020-01-22 |
| ACCLARENT, INC. | ACCLARENT NAVWIRE GW35150NZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0616 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0516 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0616M | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0616F | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0516M | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0516F | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0516MFS | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPINPLUS RSP0616MFS | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA CIRCA EP01 | 2020-01-22 |
| ACCLARENT, INC. | ACCLARENT AERA EU061655 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RS0616MFS | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RS0516MFS | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RSM110C | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RS0516M | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RS0516F | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC8524A | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RSM110 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RSS0 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA VORTEX 2 RV02 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RSF70 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RS0616M | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SPIN RS0616F | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA ULTIRRA BC0724RU | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA ULTIRRA BC0716RU | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA ULTIRRA BC0616RU | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA ULTIRRA BC0516RU | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC1640A | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC1240A | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA LUMA SENTRY SIS100B | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC0724A | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC0524A | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SIDEKICK LP SDKKLPZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA SIDEKICK LP SDKKLP | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC110RF | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC090RF | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC070CRF | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC000RF | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC1440A | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC1040A | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC110RFZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC090RFZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC070CRFZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA FLEX GC000RFZ | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC1440AZ | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC1040AZ | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC0724AZ | 2020-01-22 |
| ACCLARENT, INC. | INSPIRA AIR BC0524AZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA LUMA SISLGCASTORZ | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA LUMA SISLGCAOLYMP | 2020-01-22 |
| ACCLARENT, INC. | ACCLARENT CYCLOPS CYE002R | 2020-01-22 |
| ACCLARENT, INC. | ACCLARENT CYCLOPS CYE002 | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA LUMA SISLGCAWOLF | 2020-01-22 |
| ACCLARENT, INC. | RELIEVA LUMA SISLGCAACMI | 2020-01-22 |
ACCLARENT, INC. | Relieva Ultirra Sinus Balloon Catheter | 2019-08-26 |
ACCLARENT, INC. | TruDi NAVWIRE | 2019-05-08 |
Acclarent, Inc. | TruDi NAV Wire | 2019-05-03 |
Acclarent, Inc. | RELIEVA ULTIRRA Sinus Balloon Catheter | 2019-05-03 |
ACCLARENT, INC. | Relieva Tract Balloon Dilation System | 2019-04-25 |
Acclarent, Inc. | Relieva Tract Balloon Dilation System | 2019-04-19 |
ACCLARENT, INC. | TruDi NAV Suction | 2018-10-09 |
ACCLARENT, INC. | TruDi NAV Cable | 2018-10-09 |
Acclarent, Inc. | TruDi NAV Suction Instruments | 2018-07-20 |
Acclarent, Inc | Acclarent ENT Navigation System | 2018-03-10 |
ACCLARENT, INC. | Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System | 2018-01-26 |
ACCLARENT, INC. | Acclarent Relieva SpinPlus Nav Balloon Sinuplasty System | 2018-01-26 |
Acclarent, Inc. | ACCLARENT AERA Eustachian Tube Balloon Dilation System | 2018-01-16 |
Acclarent, Inc. | Relieva SpinPlus Nav Balloon Sinuplasty System | 2017-09-05 |
ACCLARENT, INC. | Acclarent Relieva Ultirra? Nav Sinus Balloon Catheter | 2016-11-15 |
ACCLARENT, INC. | Acclarent Navwire Sinus Navigation Guidewire | 2016-11-15 |
ACCLARENT, INC. | Relieva UltirraNav Sinus Balloon Catheter | 2016-10-24 |
ACCLARENT, INC. | Acclarent NavWire Sinus Navigation Guidewire | 2016-10-24 |
ACCLARENT, INC. | Acclarent Aera Eustachian Tube Balloon Dilation System | 2016-09-16 |
ACCLARENT, INC. | Acclarent AERA Eustachian Tube Balloon Dilation System | 2016-09-16 |
ACCLARENT, INC. | Scout? Multi-Sinus Dilation System | 2016-03-08 |
ACCLARENT, INC. | Relieva Scout Multi-Sinus Dilation System | 2016-02-12 |
ACCLARENT, INC. | Relieva SpinPlus Balloon Sinuplasty System | 2015-12-14 |
ACCLARENT, INC. | Relieva Circa Ethmoid Punch | 2015-09-16 |
ACCLARENT, INC. | ACCLARENT SE Inflation Device | 2015-06-09 |
ACCLARENT, INC. | TULA Iontophoresis System With Earset | 2015-05-20 |
ACCLARENT, INC. | Relieva SpinPlus Balloon Sinuplasty System | 2015-04-22 |
ACCLARENT, INC. | ACCLARENT SE Inflation Device | 2015-04-07 |
ACCLARENT, INC. | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | 2014-04-24 |
ACCLARENT, INC. | RELIEVA SCOUT SINUS DILATION SYSTEM | 2014-02-20 |
ACCLARENT, INC. | Relieva Vortex 2 | 2013-10-30 |
ACCLARENT, INC. | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | 2012-11-05 |
ACCLARENT, INC. | Relieva Luma Light Guide Cable 2 | 2012-01-18 |
ACCLARENT, INC. | Light Guide Cable Adapters | 2012-01-18 |
ACCLARENT, INC. | Relieva Spin Balloon Sinuplasty System | 2012-01-13 |
ACCLARENT, INC. | Relieva Ultirra Sinus Balloon Catheter | 2012-01-13 |
ACCLARENT, INC. | Cyclops Multi-Angle Endoscope | 2012-01-13 |
ACCLARENT, INC. | Relieva Luma Sentry Sinus Illumination System | 2012-01-13 |
ACCLARENT, INC. | Relieva Sidekick LP | 2012-01-13 |
ACCLARENT, INC. | Relieva Flex Guide Catheter | 2012-01-13 |
ACCLARENT, INC. | RELIEVA SPIN SINUS DILATION SYSTEM | 2011-10-11 |
ACCLARENT, INC. | RELIEVA STRATUS PRO MICROFLOW SPACER (FRONTAL) | 2011-10-07 |
ACCLARENT, INC. | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | 2011-08-22 |
ACCLARENT, INC. | TULA IONTOPHORESIS SYSTEM | 2011-06-16 |
ACCLARENT, INC. | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | 2011-05-27 |
ACCLARENT, INC. | ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM | 2011-04-01 |
ACCLARENT, INC. | INSPIRA AIR BALLOON DILATION SYSTEM | 2011-03-31 |
ACCLARENT, INC. | ACCLARENT CYCLOPS MULTI-ANGLE ENDOSCOPE | 2011-01-06 |
ACCLARENT, INC. | MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER | 2010-03-03 |
ACCLARENT, INC. | Inspira Air Balloon Dilation System | 2009-07-29 |
ACCLARENT, INC. | AIRWAY BALLOON CATHETER INFLATION DEVICE | 2009-06-12 |
ACCLARENT, INC. | RELIEVA STRATUS MICROFLOW SPACER | 2009-01-29 |
ACCLARENT, INC. | TYMPANOSTOMY TUBE | 2008-09-19 |
ACCLARENT, INC. | SINUS SPACER | 2008-03-19 |
ACCLARENT, INC. | RELIEVA AND RELIEVA ACELLA SINUS BALLOON CATHETER | 2008-03-11 |
ACCLARENT, INC. | IONTOPHORESIS SYSTEM | 2008-03-05 |
ACCLARENT, INC. | RELIEVA LUMA SINUS ILLUMINATION SYSTEM, MODEL SIS-100A | 2007-09-28 |
ACCLARENT, INC. | MICROENDOSCOPE | 2006-10-24 |
ACCLARENT, INC. | ETHMOID SINUS SPACER | 2006-09-15 |
ACCLARENT, INC. | RELIEVA SINUS BALLOON CATHETER | 2006-08-18 |
ACCLARENT, INC. | RELIENT NAVIGATION DEVICE | 2006-05-05 |
ACCLARENT, INC. | RELIEVA SINUS BALLOON INFLATION DEVICE | 2005-08-31 |
ACCLARENT, INC. | Acclarent Inflation Device | 2005-05-20 |
| NCAGE Code | 4LWK0 | ACCLARENT, INC. |
| CAGE Code | 4LWK0 | ACCLARENT, INC. |
| S.A.M. Registration | 4LWK0 [361092450] | ACCLARENT, INC. |
| SEC | 0001346937 | Acclarent Inc |