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FDA 510(k)

COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN

K-Number: K082012 · 2008-10-14

ApplicantCosman Medical, Inc.
Decision Date2008-10-14
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN 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 2008-10-14 under 510(k) number K082012. 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 INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN?

COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN is a medical device that received FDA 510(k) clearance on 2008-10-14. The listed applicant is Cosman Medical, Inc.. The 510(k) number is K082012.

When did COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN receive FDA 510(k) clearance?

COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN received FDA 510(k) clearance on 2008-10-14, under 510(k) number K082012.

Who is the listed applicant for COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN?

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 INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN?

The FDA product code for COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN is GXI.

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Other records listing Cosman Medical, Inc. as applicant

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.

K101131FIDUCIAL MARKERSK082051COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4K060799COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULAK053415LESIONPOINT RF CANNULAK050084COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;

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 InstrumentsK241367RF CannulaShanghai Samedical & Plastic Instruments Co., Ltd.

Official Source

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