Device Classification Name |
Instrument, Ent Manual Surgical
|
510(k) Number |
K212774 |
Device Name |
VenSure LightGuide |
Applicant |
Intersect ENT |
1555 Adams Dr. |
Menlo Park,
CA
94025
|
|
Applicant Contact |
Yoko Enrile |
Correspondent |
Intersect ENT |
1555 Adams Dr. |
Menlo Park,
CA
94025
|
|
Correspondent Contact |
Yoko Enrile |
Regulation Number | 874.4420
|
Classification Product Code |
|
Date Received | 09/01/2021 |
Decision Date | 02/04/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|