Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K152092 |
Device Name |
Resection Electrodes |
Applicant |
Olympus Winter & Ibe GmbH |
Kuehnstrasse 61 |
Hamburg,
DE
22045
|
|
Applicant Contact |
Katharina Schnackenburg |
Correspondent |
GYRUS ACMI, INC. |
136 TURNPIKE RD. |
SOUTHBOROUGH,
MA
01772
|
|
Correspondent Contact |
Graham Baillie |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/28/2015 |
Decision Date | 10/26/2015 |
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
|
|
|