510(k) K241367

RF Cannula by Shanghai Samedical & Plastic Instruments Co., Ltd. — Product Code GXI

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