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510(k) K082012

Device
COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
Applicant
COSMAN MEDICAL, INC.
510(k) number
K082012
Product code
GXI  
Decision
Substantially Equivalent (SESE)
Decision date
2008-10-14
Date received
2008-07-15
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
No

Applicant Contact#

Contact
LOUIS FALCONE
Address
76 Cambridge St. Burlington MA US 01803 01803

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GXI  #

510(k), Device, Applicant table
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
K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.2025-01-23
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

Legacy Summary#

summary

FDA Review#

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