| Device Classification Name |
electrode, electrosurgical, active, urological
|
|---|
| 510(K) Number |
K120418 |
|---|
| Models |
WA0014A,
WA22602D, WA220603D, WA22606D, WA22607D,
WA22632D,WA22621C, WA22623C,
WA22651C,WA22655C,
WA22657C
|
| Device Name |
ELECTROSUGRICAL RESECTION AND VAPORIZATION ELECTRODE SERIES |
|---|
| Applicant |
| OLYMPUS WINTER & IBE GMBH |
| 3500 corporate pkway |
| po box 610 |
|
center valley,
PA
18034 0610
|
|
| 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 (SE) |
|---|
| Classification Advisory Committee |
Gastroenterology/Urology
|
|---|
| Review Advisory Committee |
General & Plastic Surgery
|
|---|
| summary |
summary
|
| Type |
Special
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
