510(k) K192963
K192963 is an FDA 510(k) premarket notification submitted by Katalyst Surgical, LLC for the device "Kogent Torus Ultrasonic Aspirator". The FDA issued a decision of Substantially Equivalent on June 19, 2020. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Katalyst Surgical, LLC has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2020
- Date Received
- October 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type