Device Classification Name |
Electrode, Electrosurgical, Active, Urological
|
510(k) Number |
K100275 |
Device Name |
WORKING ELEMENT, RESECTION BUTTON ELECTRODE FOR PLASMA VAPORIZATON, HF-RESECTION ELECTRODE LOOPS AND BANDS |
Applicant |
OLYMPUS WINTER & IBE GMBH |
3500 CORPORATE PKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
STACY KLUESNER |
Correspondent |
OLYMPUS WINTER & IBE GMBH |
3500 CORPORATE PKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
STACY KLUESNER |
Regulation Number | 876.4300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/01/2010 |
Decision Date | 07/01/2010 |
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
|
|
|