K221763 is an FDA 510(k) clearance for the CUSA Clarity Ultrasonic Surgical Aspirator System. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Integra LifeSciences Corporation (Princeton, US). The FDA issued a Cleared decision on July 15, 2022, 28 days after receiving the submission on June 17, 2022.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K221763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2022 |
| Decision Date | July 15, 2022 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |