Device Classification Name |
endoscopic access overtube, gastroenterology-urology
|
510(k) Number |
K200770 |
Device Name |
Mini PCNL-System |
Applicant |
Trokamed GmbH |
Kleine Breite 17 |
Geisingen,
DE
78187
|
|
Applicant Contact |
Stefan Weiland |
Correspondent |
Trokamed GmbH |
Kleine Breite 17 |
Geisingen,
DE
78187
|
|
Correspondent Contact |
Stefan Weiland |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/25/2020 |
Decision Date | 07/30/2021 |
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
|
|
|