510(k) K212614
K212614 is an FDA 510(k) premarket notification submitted by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. for the device "Ultrasonic Scalpel System". The FDA issued a decision of Substantially Equivalent on July 18, 2022. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2022
- Date Received
- August 18, 2021
- 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