LRC — Instrument, Ent Manual Surgical Class I
FDA Device Classification
Classification Details
- Product Code
- LRC
- Device Class
- Class I
- Regulation Number
- 874.4420
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
| K230258 | excelent | BB 8 Sinus Dilation Kit | May 25, 2023 |
| K212774 | intersect ent | VenSure LightGuide | February 4, 2022 |
| K201398 | stryker ent | SINUSPRIME Dilation System | October 15, 2020 |
| K201115 | acclarent | Next Generation Balloon Dilation System | August 27, 2020 |
| K201472 | fiagon | VenSure Balloon Device, VenSure Nav Balloon Device | August 26, 2020 |
| K181546 | intuit medical products | Dillard Nasal Balloon Catheter | January 3, 2020 |
| K190525 | acclarent | RELIEVA ULTIRRA Sinus Balloon Catheter | May 3, 2019 |
| K181838 | 3nt medical | Sinusway Dilation System | December 20, 2018 |
| K172737 | m/s. meril life sciences private limited | MESIRE - Balloon Sinus Dilatation System | December 12, 2017 |
| K171687 | acclarent | Relieva SpinPlus Nav Balloon Sinuplasty System | September 5, 2017 |
| K161698 | acclarent | Relieva UltirraNav Sinus Balloon Catheter | October 24, 2016 |
| K160770 | sinusys corporation | Vent-Os Sinus Dilation family | June 29, 2016 |
| K153341 | acclarent | Relieva Scout Multi-Sinus Dilation System | February 12, 2016 |
| K152121 | medtronic xomed | NuVent EM Sinus Dilation System | December 1, 2015 |
| K152435 | entellus medical | PassAssist LED Light Fiber | November 20, 2015 |
| K152434 | entellus medical | XprESS Multi-Sinus Dilation System | November 20, 2015 |
| K143738 | intuit medical products | DSS Sinusplasty Balloon Catheter | August 27, 2015 |
| K143541 | acclarent | Relieva SpinPlus Balloon Sinuplasty System | April 22, 2015 |
| K150172 | acclarent | ACCLARENT SE Inflation Device | April 7, 2015 |
| K142252 | entellus medical | XprESS Multi-Sinus Dilation Tool | October 17, 2014 |