Device Classification Name |
hysteroscope (and accessories)
|
510(k) Number |
K180752 |
Device Name |
Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole |
Applicant |
Corinth MedTech, Inc. |
1601 S. De Anza Blvd, Suite 221 |
Cupertino,
CA
95014
|
|
Applicant Contact |
Sandeep Saboo |
Correspondent |
Corinth MedTech, Inc. |
1601 S. De Anza Blvd, Suite 221 |
Cupertino,
CA
95014
|
|
Correspondent Contact |
Sandeep Saboo |
Regulation Number | 884.1690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/22/2018 |
Decision Date | 07/25/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|