Device Classification Name |
Implantable Transprostatic Tissue Retractor System
|
510(k) Number |
K200441 |
Device Name |
UroLift Advanced Tissue Control (ATC) System |
Applicant |
NeoTract, Inc. |
4155 Hopyard Rd. |
Pleasanton,
CA
94588
|
|
Applicant Contact |
Brian Gall |
Correspondent |
NeoTract, Inc. |
4155 Hopyard Rd. |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
Brian Gall |
Regulation Number | 876.5530
|
Classification Product Code |
|
Date Received | 02/24/2020 |
Decision Date | 06/05/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|