510(k) K112231
K112231 is an FDA 510(k) premarket notification submitted by Lccs Products Limited for the device "LCCS INSULATED SPINAL NEEDLE (RF CANNULA)". The FDA issued a decision of Substantially Equivalent on August 19, 2011. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Lccs Products Limited has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 2011
- Date Received
- August 4, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Probe, Radiofrequency Lesion
- Device Class
- Class II
- Regulation Number
- 882.4725
- Review Panel
- NE
- Submission Type