FDA.report

510(k) K241367

Device
RF Cannula
Applicant
Shanghai Samedical & Plastic Instruments Co., Ltd.
510(k) number
K241367
Product code
GXI
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-23
Date received
2024-05-14
Regulation
882.4725
Classification name
Probe, Radiofrequency Lesion
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Louis Li
Address
Level 1-4 & Rm. 501,506,510, Bldg. #12, #2755 Sanlu Hwy., Minhang District Shanghai CN 201100 201100

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code GXI

510(k)DeviceApplicantDecision date
K253907Disposable Radiofrequency CannulaABBOTT MEDICAL2026-04-16
K251802STAR RF Ablation SystemMerit Medical Systems, Inc.2026-02-13
K251243OneRF Trigeminal Nerve Radiofrequency ProbesNeuroone Medical Technologies Corp.2025-08-15
K242841Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)ABBOTT MEDICAL2025-05-27
K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments2025-05-15
K222281Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.2022-10-26
K213836Intracept Intraosseous Nerve Ablation SystemRelievant Medsystems, Inc.2022-03-11
K203066COOLIEF Cooled Radiofrequency Kit AdvancedAvanos Medical, Inc.2020-12-22
K190259Vesta RF CannulaBiomerics2020-02-07
K191293LCCS VC-S RF CannulaLccs Products Limited2020-01-24
K190504Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF GeneratorRelievant Medsystems2019-05-03
K190256Rulo Radiofrequency Lesion ProbeEpimed International, Inc.2019-03-08
K183177Nitinol Thermocouple (TCN) ElectrodeBoston Scientific Corporation2019-03-08
K180369Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)Relievant Medsystems2018-09-14
K170827INTRACEPT Intraosseous Nerve Ablation SystemRelievant Medsystems2017-08-09