The following data is part of a premarket notification filed by Katalyst Surgical, Llc with the FDA for Kogent Torus Ultrasonic Aspirator.
| Device ID | K192963 |
| 510k Number | K192963 |
| Device Name: | Kogent Torus Ultrasonic Aspirator |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 |
| Contact | Meryl Koch Wilhelm |
| Correspondent | Meryl Koch Wilhelm Katalyst Surgical, LLC 754 Goddard Avenue Chesterfield, MO 63005 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-23 |
| Decision Date | 2020-06-19 |