Device Classification Name |
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
|
510(k) Number |
K193516 |
Device Name |
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 |
Applicant |
Gynesonics, Inc |
600 Chesapeake Drive |
Redwood City,
CA
94063
|
|
Applicant Contact |
Diane King |
Correspondent |
Gynesonics, Inc |
600 Chesapeake Drive |
Redwood City,
CA
94063
|
|
Correspondent Contact |
Diane King |
Regulation Number | 884.4160
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/19/2019 |
Decision Date | 05/04/2020 |
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
|
|
|