The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Harmonic Wave Coagulating Shears With Scissor Handel And Hand Control, Model Wave18s; Harmonic Disposable Torque Wrench.
| Device ID | K062000 |
| 510k Number | K062000 |
| Device Name: | HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Carol Walsh |
| Correspondent | Carol Walsh ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-17 |
| Decision Date | 2006-09-25 |
| Summary: | summary |