510(k) K042375
K042375 is an FDA 510(k) premarket notification submitted by Technomed Europe for the device "SMK, CX, CXE, RCN". The FDA issued a decision of Substantially Equivalent on October 26, 2004. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Technomed Europe has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 26, 2004
- Date Received
- September 1, 2004
- 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