The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Ace Laparoscopic 5mm Diameter Shears 36cm Length + Adaptive Tissue Technology.
| Device ID | K121550 |
| 510k Number | K121550 |
| Device Name: | HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Marcia Aretz |
| Correspondent | Marcia Aretz 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 | 2012-05-25 |
| Decision Date | 2012-08-22 |
| Summary: | summary |