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FDA 510(k)

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode

K-Number: K152642 · 2016-08-26

ApplicantLccs Products Limited
Decision Date2016-08-26
Product CodeGXI
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Lccs Products Limited. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K152642. 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 LCCS Disposable RF Electrode, LCCS Reusable RF Electrode?

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Lccs Products Limited. The 510(k) number is K152642.

When did LCCS Disposable RF Electrode, LCCS Reusable RF Electrode receive FDA 510(k) clearance?

LCCS Disposable RF Electrode, LCCS Reusable RF Electrode received FDA 510(k) clearance on 2016-08-26, under 510(k) number K152642.

Who is the listed applicant for LCCS Disposable RF Electrode, LCCS Reusable RF Electrode?

The FDA 510(k) record lists Lccs Products Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LCCS Disposable RF Electrode, LCCS Reusable RF Electrode?

The FDA product code for LCCS Disposable RF Electrode, LCCS Reusable RF Electrode is GXI.

Other records listing Lccs Products Limited 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.

K191293LCCS VC-S RF Cannula

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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