The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Clarity Ultrasonic Surgical Aspirator System.
| Device ID | K221835 |
| 510k Number | K221835 |
| Device Name: | CUSA Clarity Ultrasonic Surgical Aspirator System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Integra Lifesciences Corporation 1100 Campus Road Princeton, NJ 08540 |
| Contact | Alexandra Wells |
| Correspondent | Alexandra Wells Integra Lifesciences Corporation 1100 Campus Road Princeton, NJ 08540 |
| 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 | 2022-06-23 |
| Decision Date | 2022-08-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30381780536363 | K221835 | 000 |
| 10381780536352 | K221835 | 000 |