The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Ace+ Shears 23 Cm Length With Advanced Hemostasis, Harmonic Ace + Laparoscopic Shears 36 Cm Length With Advance.
| Device ID | K132612 |
| 510k Number | K132612 |
| Device Name: | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Brian Godwin |
| Correspondent | Brian Godwin ETHICON ENDO-SURGERY, LLC 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 | 2013-08-21 |
| Decision Date | 2013-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40705036014677 | K132612 | 000 |
| 40705036014639 | K132612 | 000 |
| 40705036014622 | K132612 | 000 |