VenSure LightGuide
FDA 510(k) clearance K212774 · decided 2022-02-04
Clearance details
- K-number
- K212774
- Device name
- VenSure LightGuide
- Applicant
- Intersect Ent.
- Decision
- Substantially Equivalent
- Date received
- 2021-09-01
- Decision date
- 2022-02-04
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- LRC
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Menlo Park, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BB 8 Sinus Dilation Kit (K230258) | Excelent, Inc. | 2023-05-25 |
| SINUSPRIME Dilation System (K201398) | Stryker Ent | 2020-10-15 |
| Next Generation Balloon Dilation System (K201115) | Acclarent, Inc. | 2020-08-27 |
| VenSure Balloon Device, VenSure Nav Balloon Device (K201472) | Fiagon GmbH | 2020-08-26 |
| Dillard Nasal Balloon Catheter (K181546) | Intuit Medical Products, LLC | 2020-01-03 |
| RELIEVA ULTIRRA Sinus Balloon Catheter (K190525) | Acclarent, Inc. | 2019-05-03 |
| Sinusway Dilation System (K181838) | 3nt Medical , Ltd. | 2018-12-20 |
| MESIRE - Balloon Sinus Dilatation System (K172737) | M/S. Meril Life Sciences Private Limited | 2017-12-12 |
| Relieva SpinPlus Nav Balloon Sinuplasty System (K171687) | Acclarent, Inc. | 2017-09-05 |
| Relieva UltirraNav Sinus Balloon Catheter (K161698) | Acclarent, Inc. | 2016-10-24 |
| Vent-Os Sinus Dilation family (K160770) | Sinusys Corporation | 2016-06-29 |
| Relieva Scout Multi-Sinus Dilation System (K153341) | Acclarent, Inc. | 2016-02-12 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Propel Contour Sinus Implant (P100044/S058) | Intersect Ent. | 2025-11-07 |
| PROPEL, PROPEL MINI and PROPEL CONTOUR (P100044/S057) | Intersect Ent. | 2025-06-18 |
| Propel®, Propel® Mini, Propel® Contour Sinus Implants (P100044/S056) | Intersect Ent. | 2025-02-12 |
| Propel® Contour Sinus Implant (P100044/S055) | Intersect Ent. | 2024-11-25 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System, Propel Contor (P100044/S054) | Intersect Ent. | 2024-10-11 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S053) | Intersect Ent. | 2024-10-02 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS) (P100044/S052) | Intersect Ent. | 2024-09-10 |
| Propel Sinus Implant, Propel Mini Sinus Implant, Propel Mini Sinus Implant with Straight Delivery System (SDS), Propel C (P100044/S051) | Intersect Ent. | 2022-12-22 |