510(k) K241367
K241367 is an FDA 510(k) premarket notification submitted by Shanghai Samedical & Plastic Instruments Co., Ltd. for the device "RF Cannula". The FDA issued a decision of Substantially Equivalent on January 23, 2025. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Shanghai Samedical & Plastic Instruments Co., Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 23, 2025
- Date Received
- May 14, 2024
- 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