Product code LRC
- Device name
- Instrument, Ent Manual Surgical
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4420
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230258 | BB 8 Sinus Dilation Kit | Excelent, Inc. | 2023-05-25 |
| K212774 | VenSure LightGuide | Intersect Ent. | 2022-02-04 |
| K201398 | SINUSPRIME Dilation System | Stryker Ent | 2020-10-15 |
| K201115 | Next Generation Balloon Dilation System | Acclarent, Inc. | 2020-08-27 |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon Device | Fiagon GmbH | 2020-08-26 |
| K181546 | Dillard Nasal Balloon Catheter | Intuit Medical Products, LLC | 2020-01-03 |
| K190525 | RELIEVA ULTIRRA Sinus Balloon Catheter | Acclarent, Inc. | 2019-05-03 |
| K181838 | Sinusway Dilation System | 3nt Medical , Ltd. | 2018-12-20 |
| K172737 | MESIRE - Balloon Sinus Dilatation System | M/S. Meril Life Sciences Private Limited | 2017-12-12 |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty System | Acclarent, Inc. | 2017-09-05 |
| K161698 | Relieva UltirraNav Sinus Balloon Catheter | Acclarent, Inc. | 2016-10-24 |
| K160770 | Vent-Os Sinus Dilation family | Sinusys Corporation | 2016-06-29 |
| K153341 | Relieva Scout Multi-Sinus Dilation System | Acclarent, Inc. | 2016-02-12 |
| K152121 | NuVent EM Sinus Dilation System | Medtronic Xomed, Inc. | 2015-12-01 |
| K152434 | XprESS Multi-Sinus Dilation System | Entellus Medical, Inc. | 2015-11-20 |
| K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015-11-20 |
| K143738 | DSS Sinusplasty Balloon Catheter | Intuit Medical Products, LLC | 2015-08-27 |
| K143541 | Relieva SpinPlus Balloon Sinuplasty System | Acclarent, Inc. | 2015-04-22 |
| K150172 | ACCLARENT SE Inflation Device | Acclarent, Inc. | 2015-04-07 |
| K142252 | XprESS Multi-Sinus Dilation Tool | Entellus Medical, Inc. | 2014-10-17 |
| K141916 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | 2014-08-07 |
| K140160 | RELIEVA SCOUT SINUS DILATION SYSTEM | Acclarent, Inc. | 2014-02-20 |
| K133563 | PATHASSIST LIGHT SEEKER | Entellus Medical, Inc. | 2013-12-20 |
| K130736 | BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS | Helix Medical, LLC | 2013-12-17 |
| K133016 | VENT-OS SINUS DILATION SYSTEM | Sinusys Corporation | 2013-12-09 |
| K132297 | EM SINUS DILATION SYSTEM | Medtronic Xomed, Inc. | 2013-11-05 |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 2013-10-04 |
| K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT | Arthrocare Corp. | 2013-10-04 |
| K130503 | PATHASSIST LED LIGHT FIBER | Entellus Medical, Inc. | 2013-06-11 |
| K120280 | RELIEVA SEEKER BALLOON SINUPLASTY SYSTEM | Acclarent, Inc. | 2012-11-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 09348811172143 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-03-18 |
| 08904461031080 | OSSEOUS-Ear/Nasal Extractor | EON MEDITECH PRIVATE LIMITED | 2026-03-13 |
| 08904461055697 | OSSEOUS-Capsule | EON MEDITECH PRIVATE LIMITED | 2026-03-13 |
| 10381780539315 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539773 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539568 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539544 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539513 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| 10381780539537 | MicroFrance® | INTEGRA MICROFRANCE | 2024-05-29 |
| G586NS8684A10 | Novo Surgical | NOVO SURGICAL, INC. | 2024-02-22 |
| 10381780490401 | Integra® MicroFrance® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-09-14 |
| 00821925011625 | GYRUS ACMI, INC | Gyrus ACMI, LLC | 2018-09-07 |
| 00821925012844 | Gyrus ACMI | Gyrus ACMI, LLC | 2018-09-06 |
| 10381780190196 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780190189 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780190172 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-04-03 |
| 10381780198611 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-01 |
| 10381780198604 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-01 |
| 10381780458203 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-01 |
| 10381780458210 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-01 |
| 10381780458227 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-03-01 |
| 10381780393924 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |
| 10381780393931 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |
| 10381780200840 | Integra® Jarit® | INTEGRA LIFESCIENCES PRODUCTION CORPORATION | 2018-02-16 |
| 10381780110293 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-12 |
| 10381780105305 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10381780105299 | MicroFrance® | INTEGRA MICROFRANCE | 2018-01-10 |
| 10705031063570 | ACCLARENT BALLOON INFLATION DEVICE | ACCLARENT, INC. | 2016-10-01 |
| 10705031200258 | RELIEVA ULTIRRA | ACCLARENT, INC. | 2016-10-01 |
| 10705031200272 | RELIEVA ULTIRRA | ACCLARENT, INC. | 2016-10-01 |