The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Hook.
| Device ID | K151136 |
| 510k Number | K151136 |
| Device Name: | HARMONIC HOOK |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, LLC 475 CALLE C Guaynabo, PR 00969 |
| Contact | Marjorie Medina |
| Correspondent | Brian Godwin ETHICON ENDO-SURGERY, INC. 4545 CREEK ROAD 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 | 2015-04-29 |
| Decision Date | 2016-03-04 |
| Summary: | summary |