Cleared Traditional

RF Cannula

K241367 · Shanghai Samedical & Plastic Instruments Co., Ltd. · Neurology

Jan 2025

Decision

254d

Days

Class 2

Risk

About This 510(k) Submission

K241367 is an FDA 510(k) clearance for the RF Cannula, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Shanghai Samedical & Plastic Instruments Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 23, 2025, 254 days after receiving the submission on May 14, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number	K241367 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 14, 2024
Decision Date	January 23, 2025
Days to Decision	254 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF