FDA 510(k)

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;

K-Number: K050084 · 2005-03-17

Decision Date2005-03-17

Product CodeGXI

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; is the device name listed in this FDA 510(k) record. The listed applicant is Cosman Medical, Inc.. It received FDA 510(k) clearance on 2005-03-17 under 510(k) number K050084. 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 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;?

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; is a medical device that received FDA 510(k) clearance on 2005-03-17. The listed applicant is Cosman Medical, Inc.. The 510(k) number is K050084.

When did COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; receive FDA 510(k) clearance?

COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; received FDA 510(k) clearance on 2005-03-17, under 510(k) number K050084.

Who is the listed applicant for COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;?

The FDA 510(k) record lists Cosman Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;?

The FDA product code for COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; is GXI.

Related Clinical Trials

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.

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Other records listing Cosman Medical, Inc. as applicant

K101131FIDUCIAL MARKERS K082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 K082012COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN K060799COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA K053415LESIONPOINT RF CANNULA

Related Devices (Code: GXI)

K253907Disposable Radiofrequency CannulaABBOTT MEDICAL K251802STAR 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 MEDICAL K250213OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)Stryker Instruments K241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

Official Source

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