The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Excel+ Ultrasonic Surgical Aspirator System.
| Device ID | K172595 |
| 510k Number | K172595 |
| Device Name: | CUSA Excel+ Ultrasonic Surgical Aspirator System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Contact | Alexandra Wells |
| Correspondent | Alexandra Wells Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-29 |
| Decision Date | 2017-09-28 |