| Device Classification Name |
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
|
|---|
| 510(k) Number |
K021266 |
|---|
| Device Name |
ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 |
|---|
| Applicant |
| Ethicon Endo-Surgery, Inc. |
| 4545 Creek Rd. |
|
Cincinnati,
OH
45242
|
|
| Applicant Contact |
KEN CHARAK |
| Correspondent |
| Ethicon Endo-Surgery, Inc. |
| 4545 Creek Rd. |
|
Cincinnati,
OH
45242
|
|
| Correspondent Contact |
KEN CHARAK |
| Regulation Number | 876.4300 |
|---|
| Classification Product Code |
|
|---|
| Date Received | 04/22/2002 |
|---|
| Decision Date | 09/27/2002 |
|---|
| 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
|
|---|
Predetermined Change
Control Plan Authorized |
No
|
|---|