K243930 is an FDA 510(k) clearance for the Sonopet iQ Ultrasonic Aspirator System (5500-050-000). This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Stryker Instruments (Portage, US). The FDA issued a Cleared decision on March 24, 2025, 94 days after receiving the submission on December 20, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K243930 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2024 |
| Decision Date | March 24, 2025 |
| Days to Decision | 94 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |