MESIRE - Balloon Sinus Dilatation System
FDA 510(k) K172737 · M/S. Meril Life Sciences Private Limited
510(k) numberK172737
Submission
- Device name
- MESIRE - Balloon Sinus Dilatation System
- Applicant
- M/S. Meril Life Sciences Private Limited
Chala, Vapi, IN - Received
- September 11, 2017
- Decision date
- December 12, 2017
- 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 |
| K171687 | Relieva SpinPlus Nav Balloon Sinuplasty SystemLRC · Traditional | Acclarent, Inc. | 09/05/2017SE |
| K161698 | Relieva UltirraNav Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 10/24/2016SE |
Questions and answers
When was MESIRE - Balloon Sinus Dilatation System cleared by the FDA?
MESIRE - Balloon Sinus Dilatation System (K172737) received a 510(k) decision of Substantially Equivalent on December 12, 2017, 92 days after the submission was received.
What is the product code of K172737?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.