K192963 is an FDA 510(k) clearance for the Kogent Torus Ultrasonic Aspirator. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Katalyst Surgical, LLC (Chesterfield, US). The FDA issued a Cleared decision on June 19, 2020, 240 days after receiving the submission on October 23, 2019.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K192963 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 2019 |
| Decision Date | June 19, 2020 |
| Days to Decision | 240 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL - Instrument, Ultrasonic Surgical |
| Device Class | - |