K200774 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 June 23, 2020, 90 days after receiving the submission on March 25, 2020.
This device falls under the Neurology FDA review panel.
| 510(k) Number | K200774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2020 |
| Decision Date | June 23, 2020 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |