The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endo Window High Frequency Electrocautery Device, Model Ew018.
| Device ID | K021266 |
| 510k Number | K021266 |
| Device Name: | ENDO WINDOW HIGH FREQUENCY ELECTROCAUTERY DEVICE, MODEL EW018 |
| Classification | Unit, Electrosurgical, Endoscopic (with Or Without Accessories) |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Ken Charak |
| Correspondent | Ken Charak ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | KNS |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-22 |
| Decision Date | 2002-09-27 |
| Summary: | summary |