The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Ace Curved Shears With Ergonomic Handle.
| Device ID | K132522 |
| 510k Number | K132522 |
| Device Name: | HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | David Locke |
| Correspondent | David Locke 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 | 2013-08-12 |
| Decision Date | 2013-12-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036000970 | K132522 | 000 |