FDA 510(k) Applications for Medical Device Product Code "LRC"
(Instrument, Ent Manual Surgical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K181838 | 3NT Medical Ltd. | Sinusway Dilation System | 12/20/2018 |
| K201115 | Acclarent Inc. | Next Generation Balloon Dilation System | 08/27/2020 |
| K150172 | ACCLARENT, INC. | ACCLARENT SE Inflation Device | 04/07/2015 |
| K153341 | ACCLARENT, INC. | Relieva Scout Multi-Sinus Dilation System | 02/12/2016 |
| K140160 | ACCLARENT, INC. | RELIEVA SCOUT SINUS DILATION SYSTEM | 02/20/2014 |
| K120280 | ACCLARENT, INC. | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | 11/05/2012 |
| K061903 | ACCLARENT, INC. | RELIEVA SINUS BALLOON CATHETER | 08/18/2006 |
| K052198 | ACCLARENT, INC. | RELIEVA SINUS BALLOON INFLATION DEVICE | 08/31/2005 |
| K111254 | ACCLARENT, INC. | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | 08/22/2011 |
| K111875 | ACCLARENT, INC. | RELIEVA SPIN SINUS DILATION SYSTEM | 10/11/2011 |
| K143541 | ACCLARENT, INC. | Relieva SpinPlus Balloon Sinuplasty System | 04/22/2015 |
| K171687 | Acclarent, Inc. | Relieva SpinPlus Nav Balloon Sinuplasty System | 09/05/2017 |
| K190525 | Acclarent, Inc. | RELIEVA ULTIRRA Sinus Balloon Catheter | 05/03/2019 |
| K161698 | ACCLARENT, INC. | Relieva UltirraNav Sinus Balloon Catheter | 10/24/2016 |
| K131709 | ARTHROCARE CORP. | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT | 10/04/2013 |
| K093007 | Entellus Medical, Inc. | ENTELLUS MEDICAL BALLOON DEVICE | 02/05/2010 |
| K072302 | Entellus Medical, Inc. | ENTELLUS MEDICAL RS-SERIES SYSTEM | 04/08/2008 |
| K110739 | Entellus Medical, Inc. | ENTELLUS MEDICAL SINUS GUIDEWIRE | 06/14/2011 |
| K091681 | Entellus Medical, Inc. | FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) | 07/08/2009 |
| K110158 | Entellus Medical, Inc. | ILLUMINATING SINUS SEEKER | 06/07/2011 |
| K081542 | Entellus Medical, Inc. | MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM | 06/27/2008 |
| K152435 | ENTELLUS MEDICAL, INC. | PassAssist LED Light Fiber | 11/20/2015 |
| K130503 | Entellus Medical, Inc. | PATHASSIST LED LIGHT FIBER | 06/11/2013 |
| K141916 | Entellus Medical, Inc. | PATHASSIST LED LIGHT FIBER | 08/07/2014 |
| K111763 | Entellus Medical, Inc. | PATHASSIST LIGHT FIBER | 09/15/2011 |
| K120962 | Entellus Medical, Inc. | PATHASSIST LIGHT FIBER | 04/27/2012 |
| K133563 | Entellus Medical, Inc. | PATHASSIST LIGHT SEEKER | 12/20/2013 |
| K113522 | Entellus Medical, Inc. | PATHASSIST LIGHT SEEKER | 01/27/2012 |
| K120735 | Entellus Medical, Inc. | PATHASSIT LIGHT SEEKER | 04/02/2012 |
| K102003 | Entellus Medical, Inc. | XPRESS BALLOON DEVICE | 10/22/2010 |
| K152434 | ENTELLUS MEDICAL, INC. | XprESS Multi-Sinus Dilation System | 11/20/2015 |
| K121943 | Entellus Medical, Inc. | XPRESS MULTI-SINUS DILATION TOOL | 08/22/2012 |
| K132440 | Entellus Medical, Inc. | XPRESS MULTI-SINUS DILATION TOOL | 10/04/2013 |
| K142252 | ENTELLUS MEDICAL, INC. | XprESS Multi-Sinus Dilation Tool | 10/17/2014 |
| K112506 | Entellus Medical, Inc. | XPRESS MULTI-SINUS DILATION TOOL | 12/21/2011 |
| K121174 | Entellus Medical, Inc. | XPRESS MULTI-SINUS DILATION TOOL | 05/17/2012 |
| K121351 | ENTRIGUE SURGICAL, INC. | SINUS DILATION SYSTEM | 08/29/2012 |
| K230258 | Excelent Inc. | BB 8 Sinus Dilation Kit | 05/25/2023 |
| K990366 | EXMOOR PLASTICS LTD. | EXMOOR SUCTION CLEARANCE KIT | 03/05/1999 |
| K043527 | EXPLORAMED NC1, INC. | RELIEVA SINUS BALLOON DILATION CATHETER | 04/05/2005 |
| K201472 | Fiagon GmbH | VenSure Balloon Device, VenSure Nav Balloon Device | 08/26/2020 |
| K130736 | HELIX MEDICAL, LLC | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | 12/17/2013 |
| K212774 | Intersect ENT | VenSure LightGuide | 02/04/2022 |
| K181546 | Intuit Medical Products, LLC | Dillard Nasal Balloon Catheter | 01/03/2020 |
| K143738 | Intuit Medical Products, LLC | DSS Sinusplasty Balloon Catheter | 08/27/2015 |
| K970018 | L.W. WARD AND ASSOC., INC. | FAST TRACT TRANSTRACHEAL PROCEDURE KIT | 03/28/1997 |
| K172737 | M/s. Meril Life Sciences Private Limited | MESIRE - Balloon Sinus Dilatation System | 12/12/2017 |
| K132297 | MEDTRONIC XOMED, INC. | EM SINUS DILATION SYSTEM | 11/05/2013 |
| K152121 | MEDTRONIC XOMED, INC. | NuVent EM Sinus Dilation System | 12/01/2015 |
| K160770 | SINUSYS CORPORATION | Vent-Os Sinus Dilation family | 06/29/2016 |
| K133016 | SINUSYS CORPORATION | VENT-OS SINUS DILATION SYSTEM | 12/09/2013 |
| K201398 | Stryker ENT | SINUSPRIME Dilation System | 10/15/2020 |
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