VenSure Balloon Device, VenSure Nav Balloon Device
FDA 510(k) K201472 · Fiagon GmbH
510(k) numberK201472
Submission
- Device name
- VenSure Balloon Device, VenSure Nav Balloon Device
- Applicant
- Fiagon GmbH
Hennigsdorf, DE - Received
- June 3, 2020
- Decision date
- August 26, 2020
- 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 |
| 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 |
| K161698 | Relieva UltirraNav Sinus Balloon CatheterLRC · Traditional | Acclarent, Inc. | 10/24/2016SE |
More from Acclarent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261540 | Cube 4D Navigation System, VirtuEye ProPGW · Special | 06/02/2026SE |
| K230700 | RIWOtrack Navigation SystemOLO · Traditional | 11/20/2023SE |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav…PNZ · Traditional | 05/26/2023SE |
| K211291 | Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DPGW · Traditional | 07/19/2021SE |
| K200041 | FlexPointer 1.5 Single Use, FlexTube 3 Single UsePGW · Special | 03/10/2020SE |
| K163209 | Fiagon Navigation SystemHAW · Traditional | 09/14/2017SE |
| K163416 | Fiagon Navigation PointerTube Straight and PointerTube KeatPGW · Special | 02/16/2017SE |
| K162176 | Fiagon Navigation SystemPGW · Special | 12/01/2016SE |
| K161940 | Guidewire 0.6 Single UsePGW · Special | 09/18/2016SE |
| K151156 | Fiagon Navigation SystemHAW · Traditional | 04/01/2016SE |
Questions and answers
When was VenSure Balloon Device, VenSure Nav Balloon Device cleared by the FDA?
VenSure Balloon Device, VenSure Nav Balloon Device (K201472) received a 510(k) decision of Substantially Equivalent on August 26, 2020, 84 days after the submission was received.
What is the product code of K201472?
The FDA product code is LRC – Instrument, Ent Manual Surgical, a Class I (low risk) device regulated under 21 CFR 874.4420.