Device Classification Name |
Probe, Radiofrequency Lesion
|
510(k) Number |
K180369 |
Device Name |
Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) |
Applicant |
Relievant Medsystems |
385 Moffett Park Drive, Suite 105 |
Sunnyvale,
CA
94089
|
|
Applicant Contact |
Alex DiNello |
Correspondent |
Relievant Medsystems |
385 Moffett Park Drive, Suite 105 |
Sunnyvale,
CA
94089
|
|
Correspondent Contact |
Alex DiNello |
Regulation Number | 882.4725
|
Classification Product Code |
|
Date Received | 02/12/2018 |
Decision Date | 09/14/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|