510(k) K010637
K010637 is an FDA 510(k) premarket notification submitted by Synergetics, Inc. for the device "SONOTOME ULTRASONIC ASPIRATOR TIPS". The FDA issued a decision of Substantially Equivalent on Apr 20, 2001. 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
- Apr 20, 2001
- Date Received
- Mar 5, 2001
- 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