Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K120418 |
Device Name |
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES |
Applicant |
OLYMPUS WINTER & IBE GMBH |
3500 CORPORATE PKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
SHERI MUSGNUNG |
Correspondent |
OLYMPUS WINTER & IBE GMBH |
3500 CORPORATE PKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
SHERI MUSGNUNG |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/10/2012 |
Decision Date | 06/20/2012 |
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
|
Recalls |
CDRH Recalls
|
|
|