K213824 is an FDA 510(k) clearance for the Sonopet iQ Ultrasonic Aspirator System. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on February 3, 2022, 57 days after receiving the submission on December 8, 2021.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K213824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 08, 2021 |
| Decision Date | February 03, 2022 |
| Days to Decision | 57 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |