K251162 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 October 8, 2025, 176 days after receiving the submission on April 15, 2025.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K251162 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2025 |
| Decision Date | October 08, 2025 |
| Days to Decision | 176 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |