FDA Product Code
FDA Product Code LRC — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.4420
510(k) Clearances — 65 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023-05-25 | Traditional | PDF ↗ |
| K212774 | VenSure LightGuide | Intersect Ent. | 2022-02-04 | Traditional | PDF ↗ |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | 2020-10-15 | Traditional | PDF ↗ |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020-08-27 | Traditional | PDF ↗ |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020-08-26 | Traditional | PDF ↗ |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020-01-03 | Traditional | PDF ↗ |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019-05-03 | Traditional | PDF ↗ |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | 2018-12-20 | Traditional | PDF ↗ |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017-12-12 | Traditional | PDF ↗ |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017-09-05 | Traditional | PDF ↗ |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016-10-24 | Traditional | PDF ↗ |
| K160770 | Vent-Os Sinus Dilation family | Sinusys Corporation | 2016-06-29 | Traditional | PDF ↗ |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016-02-12 | Traditional | PDF ↗ |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015-12-01 | Traditional | PDF ↗ |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015-11-20 | Traditional | PDF ↗ |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015-11-20 | Traditional | PDF ↗ |
| K143738 | DSS Sinusplasty Balloon Catheter | Intuit Medical Products, LLC | 2015-08-27 | Traditional | PDF ↗ |
| K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015-04-22 | Traditional | PDF ↗ |
| K150172 | ACCLARENT SE Inflation Device | Acclarent, Inc. | 2015-04-07 | Special | PDF ↗ |
| K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014-10-17 | Special | PDF ↗ |
| K141916 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | 2014-08-07 | Special | PDF ↗ |
| K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | Acclarent, Inc. | 2014-02-20 | Special | PDF ↗ |
| K133563 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | 2013-12-20 | Special | PDF ↗ |
| K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | Helix Medical, LLC | 2013-12-17 | Traditional | PDF ↗ |
| K133016 | VENT-OS SINUS DILATION SYSTEM | Sinusys Corporation | 2013-12-09 | Traditional | PDF ↗ |
| K132297 | EM SINUS DILATION SYSTEM | Medtronic Xomed, Inc. | 2013-11-05 | Traditional | PDF ↗ |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2013-10-04 | Special | PDF ↗ |
| K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT | Arthrocare Corp. | 2013-10-04 | Special | PDF ↗ |
| K130503 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | 2013-06-11 | Traditional | PDF ↗ |
| K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | Acclarent, Inc. | 2012-11-05 | Traditional | PDF ↗ |
| K121351 | SINUS DILATION SYSTEM | Entrigue Surgical, Inc. | 2012-08-29 | Traditional | PDF ↗ |
| K121943 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2012-08-22 | Special | PDF ↗ |
| K121174 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2012-05-17 | Special | PDF ↗ |
| K120962 | PATHASSIST LIGHT FIBER | Entellus Medical, Inc. | 2012-04-27 | Special | PDF ↗ |
| K120735 | PATHASSIT LIGHT SEEKER | Entellus Medical, Inc. | 2012-04-02 | Special | PDF ↗ |
| K113522 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | 2012-01-27 | Special | PDF ↗ |
| K112506 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2011-12-21 | Special | PDF ↗ |
| K111875 | RELIEVA SPIN SINUS DILATION SYSTEM | Acclarent, Inc. | 2011-10-11 | Traditional | PDF ↗ |
| K111763 | PATHASSIST LIGHT FIBER | Entellus Medical, Inc. | 2011-09-15 | Traditional | PDF ↗ |
| K111254 | RELIEVA SOLO ELITE SINUS BALLOON CATHETER | Acclarent, Inc. | 2011-08-22 | Traditional | PDF ↗ |
| K110739 | ENTELLUS MEDICAL SINUS GUIDEWIRE | Entellus Medical, Inc. | 2011-06-14 | Traditional | PDF ↗ |
| K110158 | ILLUMINATING SINUS SEEKER | Entellus Medical, Inc. | 2011-06-07 | Traditional | PDF ↗ |
| K102003 | XPRESS BALLOON DEVICE | Entellus Medical, Inc. | 2010-10-22 | Traditional | PDF ↗ |
| K093007 | ENTELLUS MEDICAL BALLOON DEVICE | Entellus Medical, Inc. | 2010-02-05 | Traditional | PDF ↗ |
| K091681 | FINESS SINUS TREATMENT SYSTEM (ACCESS SHEATH COMPONENT) | Entellus Medical, Inc. | 2009-07-08 | Special | PDF ↗ |
| K081542 | MODIFICATION TO ENTELLUS MEDICAL RS-SERIES SYSTEM | Entellus Medical, Inc. | 2008-06-27 | Special | PDF ↗ |
| K072302 | ENTELLUS MEDICAL RS-SERIES SYSTEM | Entellus Medical, Inc. | 2008-04-08 | Traditional | PDF ↗ |
| K061903 | RELIEVA SINUS BALLOON CATHETER | Acclarent, Inc. | 2006-08-18 | Special | PDF ↗ |
| K052198 | RELIEVA SINUS BALLOON INFLATION DEVICE | Acclarent, Inc. | 2005-08-31 | Traditional | PDF ↗ |
| K043527 | RELIEVA SINUS BALLOON DILATION CATHETER | Exploramed Nc1, Inc. | 2005-04-05 | Traditional | PDF ↗ |
| K990366 | EXMOOR SUCTION CLEARANCE KIT | Exmoor Plastics , Ltd. | 1999-03-05 | Traditional | PDF ↗ |
| K970018 | FAST TRACT TRANSTRACHEAL PROCEDURE KIT | L.W. Ward and Assoc., Inc. | 1997-03-28 | Traditional | PDF ↗ |
| K942745 | EXMOOR SINGLE USE MYRINGOTOMES | Exmoor Plastics , Ltd. | 1994-09-02 | Traditional | PDF ↗ |
| K942746 | SUCKER ENDS (ZOELLNER) | Exmoor Plastics , Ltd. | 1994-08-24 | Traditional | PDF ↗ |
| K942064 | DISPOSABLE NASAL RONGEUR | United States Surgical, A Division of Tyco Healthc | 1994-06-08 | Traditional | PDF ↗ |
| K942063 | DISPOSABLE NASAL SCISSOR | United States Surgical, A Division of Tyco Healthc | 1994-06-08 | Traditional | PDF ↗ |
| K942065 | DISPOSABLE ENT PUNCH | United States Surgical, A Division of Tyco Healthc | 1994-06-06 | Traditional | PDF ↗ |
| K933770 | FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE | Mahe-Medizintechnik | 1994-03-23 | Traditional | PDF ↗ |
| K931793 | SYMBIOSIS ENT SURGICAL INSTRUMENTS | Symbiosis Corp. | 1993-07-22 | Traditional | PDF ↗ |
| K930292 | HOUSE-BELLUCCI ALLIGATOR SCISSORS | Thomasville Medical Assoc. | 1993-03-19 | Traditional | PDF ↗ |
| K920988 | ATMOS MIRROR WARMER | Jedmed Instrument Co. | 1992-05-15 | Traditional | PDF ↗ |
| K892504 | 'EXMOOR' SINGLE USE SUCTION TUBE | Exmoor Plastics , Ltd. | 1989-06-22 | Traditional | PDF ↗ |
| K884631 | FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135) | Xomed, Inc. | 1989-03-22 | Traditional | PDF ↗ |
| K873044 | POREX OTOLOGY INSTRUMENTS | Porex Medical | 1987-09-04 | Traditional | PDF ↗ |
| K864938 | 'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR | Exmoor Plastics , Ltd. | 1987-03-23 | Traditional | PDF ↗ |
Product code LRC · Class I · Ear, Nose, Throat. Data: openFDA.