510(k) K020220
K020220 is an FDA 510(k) premarket notification submitted by Synergetics, Inc. for the device "ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE". The FDA issued a decision of Substantially Equivalent on August 23, 2002. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Synergetics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2002
- Date Received
- January 22, 2002
- 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