Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K171965 |
Device Name |
Resection Electrodes with HF cable |
Applicant |
Olympus Winter & Ibe GmbH |
Kuehnstrasse 61 |
Hamburg,
DE
22045
|
|
Applicant Contact |
Jan-Oliver Upmeier |
Correspondent |
Gyrus ACMI, Inc. |
136 Turnpike Road |
Southborough,
MA
01772
|
|
Correspondent Contact |
Dolan Mills |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 06/30/2017 |
Decision Date | 09/28/2017 |
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
|
Recalls |
CDRH Recalls
|
|
|