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FDA 510(k)

RENEW NEUROSTIMULATION SYSTEM

K-Number: K000852 · 2001-01-19

ApplicantAdvanced Neuromodulation Systems
Decision Date2001-01-19
Product CodeGZF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

RENEW NEUROSTIMULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Neuromodulation Systems. It received FDA 510(k) clearance on 2001-01-19 under 510(k) number K000852. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RENEW NEUROSTIMULATION SYSTEM?

RENEW NEUROSTIMULATION SYSTEM is a medical device that received FDA 510(k) clearance on 2001-01-19. The listed applicant is Advanced Neuromodulation Systems. The 510(k) number is K000852.

When did RENEW NEUROSTIMULATION SYSTEM receive FDA 510(k) clearance?

RENEW NEUROSTIMULATION SYSTEM received FDA 510(k) clearance on 2001-01-19, under 510(k) number K000852.

Who is the listed applicant for RENEW NEUROSTIMULATION SYSTEM?

The FDA 510(k) record lists Advanced Neuromodulation Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RENEW NEUROSTIMULATION SYSTEM?

The FDA product code for RENEW NEUROSTIMULATION SYSTEM is GZF.

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Other records listing Advanced Neuromodulation Systems 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.

K092371SWIFT-LOCK ANCHOR, MODEL 1192K090907PENTA LEAD KITS, MODELS: 3227-3234K081208CINCH ANCHOR, MODEL 1194K072462WIDE SPACED QUATTRODE LEADSK070847TRIAL CABLE, 3009K063080TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS

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Related Devices (Code: GZF)

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.

K253877StimTrial Neuromodulation SystemBioventus, LLCK243782StimTrial Neuromodulation SystemBioventus, LLCK243678TalisMann Neuromodulation SystemBioventus, LLCK232415Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK233162Freedom Peripheral Nerve Stimulator (PNS) SystemCuronixK221303Neuspera Nuity SystemNeuspera Medical, Inc.

Official Source

View on FDA Database →

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

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