Device Classification Name |
Probe, Radiofrequency Lesion
|
510(k) Number |
K153272 |
Device Name |
INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set |
Applicant |
RELIEVANT MEDSYSTEMS |
2688 MIDDLEFIELD ROAD, SUITE A |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
ADAM SAVAKUS |
Correspondent |
RELIEVANT MEDSYSTEMS |
2688 MIDDLEFIELD ROAD, SUITE A |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
ADAM SAVAKUS |
Regulation Number | 882.4725
|
Classification Product Code |
|
Date Received | 11/12/2015 |
Decision Date | 07/09/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT00027352
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|