510(k) K233036
K233036 is an FDA 510(k) premarket notification submitted by Hunan Handlike Minimally Invasive Surgery Co., Ltd. for the device "Ultrasonic Surgical System". The FDA issued a decision of Substantially Equivalent on June 18, 2024. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Hunan Handlike Minimally Invasive Surgery Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 18, 2024
- Date Received
- September 25, 2023
- 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