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 |
| K131709 | SINUS DILATION SYSTEM WITH CANNULATED INSTRUMENT | Arthrocare Corp. | 2013-10-04 |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Entellus Medical, Inc. | 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 |
|---|---|---|---|
| 00190776422660 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| 00190776422684 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| 00190776422653 | Millennium | Avalign Technologies, Inc. | 2026-08-03 |
| 00190776422462 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 00190776422523 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 00190776422585 | Millennium | Avalign Technologies, Inc. | 2026-07-31 |
| 09348811102645 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-07-31 |
| 09348811102669 | INKA | The Trustee for KAISER FAMILY TRUST | 2026-07-31 |
| 00198506093814 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-29 |
| B382SD9200321070 | Surgical Direct | Surgical Direct, Inc. | 2026-07-29 |
| B382SD9200321060 | Surgical Direct | Surgical Direct, Inc. | 2026-07-29 |
| B382SD9200321000 | Surgical Direct | Surgical Direct, Inc. | 2026-07-29 |
| 00198506093807 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-29 |
| 00198506093777 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-29 |
| 00198506093593 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-29 |
| 00190776422080 | Millennium | Avalign Technologies, Inc. | 2026-07-28 |
| 00198506093227 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506093159 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506093098 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506093074 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506093067 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506093050 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506093043 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506092824 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506092787 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506092763 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506092664 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506092633 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506092442 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-28 |
| 00198506091896 | ELMED INCORPORATED | ELMED INCORPORATED | 2026-07-22 |