The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Harmonic Ace Curved Shears With Hand Control, Model Ace23p, Ace36p.
| Device ID | K042777 |
| 510k Number | K042777 |
| Device Name: | HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242 -2839 |
| Contact | Kimberly Shoemaker |
| Correspondent | Kimberly Shoemaker 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 | 2004-10-06 |
| Decision Date | 2004-12-01 |
| Summary: | summary |