The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Harmonic Ace Curved Shears With Pistol Handle And Hand Control, Model Ace23p, Ace36p.
| Device ID | K051036 |
| 510k Number | K051036 |
| Device Name: | HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Rachel D Austin |
| Correspondent | Rachel D Austin 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 | 2005-04-25 |
| Decision Date | 2005-06-02 |
| Summary: | summary |