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FDA 510(k)

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT

K-Number: K053250 · 2005-12-15

ApplicantAdvanced Neuromodulation Systems
Decision Date2005-12-15
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT 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 2005-12-15 under 510(k) number K053250. The device is classified under product code GZB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT?

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT is a medical device that received FDA 510(k) clearance on 2005-12-15. The listed applicant is Advanced Neuromodulation Systems. The 510(k) number is K053250.

When did ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT receive FDA 510(k) clearance?

ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT received FDA 510(k) clearance on 2005-12-15, under 510(k) number K053250.

Who is the listed applicant for ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT?

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 ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT?

The FDA product code for ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT is GZB.

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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: GZB)

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.

K233801Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve StimulationBoston Scientific NeuromodulationK221376Nalu Neurostimulation SystemBoston Scientific NeuromodulationK203547Nalu Neurostimulation SystemBoston Scientific NeuromodulationK202274Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kitsBoston Scientific NeuromodulationK201618Nalu Neurostimulation SCS systemBoston Scientific NeuromodulationK191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, 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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