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FDA 510(k)

PENTA LEAD KITS, MODELS: 3227-3234

K-Number: K090907 · 2009-06-02

ApplicantAdvanced Neuromodulation Systems
Decision Date2009-06-02
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PENTA LEAD KITS, MODELS: 3227-3234 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 2009-06-02 under 510(k) number K090907. 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 PENTA LEAD KITS, MODELS: 3227-3234?

PENTA LEAD KITS, MODELS: 3227-3234 is a medical device that received FDA 510(k) clearance on 2009-06-02. The listed applicant is Advanced Neuromodulation Systems. The 510(k) number is K090907.

When did PENTA LEAD KITS, MODELS: 3227-3234 receive FDA 510(k) clearance?

PENTA LEAD KITS, MODELS: 3227-3234 received FDA 510(k) clearance on 2009-06-02, under 510(k) number K090907.

Who is the listed applicant for PENTA LEAD KITS, MODELS: 3227-3234?

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 PENTA LEAD KITS, MODELS: 3227-3234?

The FDA product code for PENTA LEAD KITS, MODELS: 3227-3234 is GZB.

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Related Devices (Code: GZB)

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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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