Device Classification Name |
Implantable Transprostatic Tissue Retractor System
|
510(k) Number |
K201837 |
Device Name |
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge |
Applicant |
NeoTract, Inc. |
4155 Hopyard Road |
Pleasanton,
CA
94588
|
|
Applicant Contact |
Brian Gall |
Correspondent |
NeoTract, Inc. |
4155 Hopyard Road |
Pleasanton,
CA
94588
|
|
Correspondent Contact |
Brian Gall |
Regulation Number | 876.5530
|
Classification Product Code |
|
Date Received | 07/02/2020 |
Decision Date | 07/31/2020 |
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
|
|
|