K190070 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 April 11, 2019, 86 days after receiving the submission on January 15, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K190070 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2019 |
| Decision Date | April 11, 2019 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |