510(k) K080771
K080771 is an FDA 510(k) premarket notification submitted by Top Corp. for the device "TOP NEUROPOLE NEEDLE, MODEL SH, BL, SC, TC". The FDA issued a decision of Substantially Equivalent on Nov 10, 2008. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Top Corp. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 10, 2008
- Date Received
- Mar 19, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe, Radiofrequency Lesion
- Device Class
- Class II
- Regulation Number
- 882.4725
- Review Panel
- NE
- Submission Type
- 510(k)