Device Classification Name |
unit, electrosurgical, endoscopic (with or without accessories)
|
510(k) Number |
K150786 |
Device Name |
Rezum System |
Applicant |
NxThera, Inc. |
7351 Kirkwood Lane N. |
SUITE 138 |
Maple Grove,
MN
55369
|
|
Applicant Contact |
J. Robert Paulson, JD |
Correspondent |
Libra Medical Inc. |
8401 73rd Avenue North, Suite 63 |
Brooklyn Park,
MN
55428
|
|
Correspondent Contact |
Sew-Wah Tay |
Regulation Number | 876.4300
|
Classification Product Code |
|
Date Received | 03/25/2015 |
Decision Date | 08/27/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01912339
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|