The following data is part of a premarket notification filed by Intersect Ent with the FDA for Vensure Lightguide.
| Device ID | K212774 |
| 510k Number | K212774 |
| Device Name: | VenSure LightGuide |
| Classification | Instrument, Ent Manual Surgical |
| Applicant | Intersect ENT 1555 Adams Dr. Menlo Park, CA 94025 |
| Contact | Yoko Enrile |
| Correspondent | Yoko Enrile Intersect ENT 1555 Adams Dr. Menlo Park, CA 94025 |
| Product Code | LRC |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2022-02-04 |