Panels › Ear, Nose, Throat › Product code LRC · Class 1
Instrument, Ent Manual Surgical
Regulation 874.4420
0510(k)s in 12 months (65 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in LRC
| Company | 510(k)s | Recalls |
|---|---|---|
| Entellus Medical, Inc. | 21 | 0 |
| Acclarent, Inc. | 13 | 1 |
| Exmoor Plastics , Ltd. | 5 | 0 |
| Karl Storz Endoscopy | 0 | 3 |
| United States Surgical, A Division of Tyco Healthc | 3 | 0 |
| Intuit Medical Products, LLC | 2 | 0 |
| Medtronic Xomed, Inc. | 2 | 0 |
| Sinusys Corporation | 2 | 0 |
| 3nt Medical , Ltd. | 1 | 0 |
| Arthrocare Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 25, 2023 | K230258 | BB 8 Sinus Dilation Kit Excelent, Inc. | LRC |
| Feb 4, 2022 | K212774 | VenSure LightGuide Intersect Ent. | LRC |
| Oct 15, 2020 | K201398 | SINUSPRIME Dilation System Stryker Ent | LRC |
| Aug 27, 2020 | K201115 | Next Generation Balloon Dilation System Acclarent, Inc. | LRC |
| Aug 26, 2020 | K201472 | VenSure Balloon Device, VenSure Nav Balloon Device Fiagon GmbH, DE | LRC |
| Jan 3, 2020 | K181546 | Dillard Nasal Balloon Catheter Intuit Medical Products, LLC | LRC |
| May 3, 2019 | K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter Acclarent, Inc. | LRC |
| Dec 20, 2018 | K181838 | Sinusway Dilation System 3nt Medical , Ltd., IL | LRC |
| Dec 12, 2017 | K172737 | MESIRE - Balloon Sinus Dilatation System M/S. Meril Life Sciences Private Limited, IN | LRC |
| Sep 5, 2017 | K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System Acclarent, Inc. | LRC |
| Oct 24, 2016 | K161698 | Relieva UltirraNav Sinus Balloon Catheter Acclarent, Inc. | LRC |
| Jun 29, 2016 | K160770 | Vent-Os Sinus Dilation family Sinusys Corporation | LRC |
| Feb 12, 2016 | K153341 | Relieva Scout Multi-Sinus Dilation System Acclarent, Inc. | LRC |
| Dec 1, 2015 | K152121 | NuVent EM Sinus Dilation System Medtronic Xomed, Inc. | LRC |
| Nov 20, 2015 | K152435 | PassAssist LED Light Fiber Entellus Medical, Inc. | LRC |
| Nov 20, 2015 | K152434 | XprESS Multi-Sinus Dilation System Entellus Medical, Inc. | LRC |
| Aug 27, 2015 | K143738 | DSS Sinusplasty Balloon Catheter Intuit Medical Products, LLC | LRC |
| Apr 22, 2015 | K143541 | Relieva SpinPlus Balloon Sinuplasty System Acclarent, Inc. | LRC |
| Apr 7, 2015 | K150172 | ACCLARENT SE Inflation Device Acclarent, Inc. | LRC |
| Oct 17, 2014 | K142252 | XprESS Multi-Sinus Dilation Tool Entellus Medical, Inc. | LRC |
| Aug 7, 2014 | K141916 | PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. | LRC |
| Feb 20, 2014 | K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM Acclarent, Inc. | LRC |
| Dec 20, 2013 | K133563 | PATHASSIST LIGHT SEEKER Entellus Medical, Inc. | LRC |
| Dec 17, 2013 | K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS Helix Medical, LLC | LRC |
| Dec 9, 2013 | K133016 | VENT-OS SINUS DILATION SYSTEM Sinusys Corporation | LRC |
| Nov 5, 2013 | K132297 | EM SINUS DILATION SYSTEM Medtronic Xomed, Inc. | LRC |
| Oct 4, 2013 | K132440 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| Oct 4, 2013 | K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT Arthrocare Corp. | LRC |
| Jun 11, 2013 | K130503 | PATHASSIST LED LIGHT FIBER Entellus Medical, Inc. | LRC |
| Nov 5, 2012 | K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM Acclarent, Inc. | LRC |
| Aug 29, 2012 | K121351 | SINUS DILATION SYSTEM Entrigue Surgical, Inc. | LRC |
| Aug 22, 2012 | K121943 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| May 17, 2012 | K121174 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| Apr 27, 2012 | K120962 | PATHASSIST LIGHT FIBER Entellus Medical, Inc. | LRC |
| Apr 2, 2012 | K120735 | PATHASSIT LIGHT SEEKER Entellus Medical, Inc. | LRC |
| Jan 27, 2012 | K113522 | PATHASSIST LIGHT SEEKER Entellus Medical, Inc. | LRC |
| Dec 21, 2011 | K112506 | XPRESS MULTI-SINUS DILATION TOOL Entellus Medical, Inc. | LRC |
| Oct 11, 2011 | K111875 | RELIEVA SPIN SINUS DILATION SYSTEM Acclarent, Inc. | LRC |
| Sep 15, 2011 | K111763 | PATHASSIST LIGHT FIBER Entellus Medical, Inc. | LRC |
| Aug 22, 2011 | K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER Acclarent, Inc. | LRC |
| Jun 14, 2011 | K110739 | ENTELLUS MEDICAL SINUS GUIDEWIRE Entellus Medical, Inc. | LRC |
| Jun 7, 2011 | K110158 | ILLUMINATING SINUS SEEKER Entellus Medical, Inc. | LRC |
| Oct 22, 2010 | K102003 | XPRESS BALLOON DEVICE Entellus Medical, Inc. | LRC |
| Feb 5, 2010 | K093007 | ENTELLUS MEDICAL BALLOON DEVICE Entellus Medical, Inc. | LRC |
| Jul 8, 2009 | K091681 | FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) Entellus Medical, Inc. | LRC |
| Jun 27, 2008 | K081542 | MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. | LRC |
| Apr 8, 2008 | K072302 | ENTELLUS MEDICAL RS-SERIES SYSTEM Entellus Medical, Inc. | LRC |
| Aug 18, 2006 | K061903 | RELIEVA SINUS BALLOON CATHETER Acclarent, Inc. | LRC |
| Aug 31, 2005 | K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE Acclarent, Inc. | LRC |
| Apr 5, 2005 | K043527 | RELIEVA SINUS BALLOON DILATION CATHETER Exploramed Nc1, Inc. | LRC |
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