510(k) K953453
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1996
- Date Received
- July 19, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical, Active, Urological
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type