The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Focus Shears.
| Device ID | K100597 |
| 510k Number | K100597 |
| Device Name: | HARMONIC FOCUS SHEARS |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
| Contact | Marcia Arentz |
| Correspondent | Marcia Arentz ETHICON ENDO-SURGERY, LLC 4545 CREEK RD. Cincinnati, OH 45242 |
| 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 | 2010-03-02 |
| Decision Date | 2010-04-07 |
| Summary: | summary |