Relieva Spin Sinus Dilation System
FDA 510(k) K111875 · Acclarent, Inc.
510(k) numberK111875
Submission
- Device name
- Relieva Spin Sinus Dilation System
- Applicant
- Acclarent, Inc.
Rmenlo Park, CA, US - Received
- July 1, 2011
- Decision date
- October 11, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRC – Instrument, Ent Manual Surgical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4420
- Specialty
- Ear, Nose, Throat
Other 510(k)s with product code LRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230258 | BB 8 Sinus Dilation KitLRC · Traditional | Excelent, Inc. | 05/25/2023SE |
| K212774 | VenSure LightGuideLRC · Traditional | Intersect Ent. | 02/04/2022SE |
| K201398 | SINUSPRIME Dilation SystemLRC · Traditional | Stryker Ent | 10/15/2020SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | Acclarent, Inc. | 08/27/2020SE |
| K201472 | VenSure Balloon Device, VenSure Nav Balloon DeviceLRC · Traditional | Fiagon GmbH | 08/26/2020SE |
| K181546 | Dillard Nasal Balloon CatheterLRC · Traditional | Intuit Medical Products, LLC | 01/03/2020SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 05/03/2019SE |
| K181838 | Sinusway Dilation SystemLRC · Traditional | 3nt Medical , Ltd. | 12/20/2018SE |
| K172737 | MESIRE - Balloon Sinus Dilatation SystemLRC · Traditional | M/S. Meril Life Sciences Private Limited | 12/12/2017SE |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC · Traditional | Acclarent, Inc. | 09/05/2017SE |
More from Acclarent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | 02/19/2026SE |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemPNZ · Traditional | 12/13/2023SE |
| K231862 | TruDi® Navigation System V3 (FG-2000-00)PGW · Special | 07/21/2023SE |
| K221037 | TruDi Shaver BladePGW · Traditional | 07/20/2022SE |
| K201115 | Next Generation Balloon Dilation SystemLRC · Traditional | 08/27/2020SE |
| K201174 | TruDi CurettePGW · Traditional | 08/12/2020SE |
| K193453 | TruDi ProbePGW · Traditional | 03/23/2020SE |
| K190532 | TruDi NAV WirePGW · Traditional | 05/03/2019SE |
| K190525 | RELIEVA ULTIRRA Sinus Balloon CatheterLRC · Traditional | 05/03/2019SE |
| K183090 | Relieva Tract Balloon Dilation SystemQGK · Traditional | 04/19/2019SE |
Questions and answers
When was Relieva Spin Sinus Dilation System cleared by the FDA?
Relieva Spin Sinus Dilation System (K111875) received a 510(k) decision of Substantially Equivalent on October 11, 2011, 102 days after the submission was received.
What is the product code of K111875?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.