Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K213627 |
Device Name |
RF Vapor System |
Applicant |
Aqua Medical, Inc. |
191 West Second St. |
Santa Ana,
CA
92701
|
|
Applicant Contact |
Scott McGill |
Correspondent |
ProMedoss, Inc. |
3521 Hatwynn Rd. |
Charlotte,
NC
28269
|
|
Correspondent Contact |
Bosmat Friedman |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/17/2021 |
Decision Date | 12/17/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|