Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

RF Cannula

K-Number: K241367 · 2025-01-23

ApplicantShanghai Samedical & Plastic Instruments Co., Ltd.
Decision Date2025-01-23
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RF Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Samedical & Plastic Instruments Co., Ltd.. It received FDA 510(k) clearance on 2025-01-23 under 510(k) number K241367. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RF Cannula?

RF Cannula is a medical device that received FDA 510(k) clearance on 2025-01-23. The listed applicant is Shanghai Samedical & Plastic Instruments Co., Ltd.. The 510(k) number is K241367.

When did RF Cannula receive FDA 510(k) clearance?

RF Cannula received FDA 510(k) clearance on 2025-01-23, under 510(k) number K241367.

Who is the listed applicant for RF Cannula?

The FDA 510(k) record lists Shanghai Samedical & Plastic Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RF Cannula?

The FDA product code for RF Cannula is GXI.

Related Devices (Code: GXI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253907Disposable Radiofrequency CannulaABBOTT MEDICALK251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICALK250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker InstrumentsK222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑