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FDA 510(k)

AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX

K-Number: K010008 · 2001-07-16

ApplicantMicronet Medical, Inc.
Decision Date2001-07-16
Product CodeGZB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX is the device name listed in this FDA 510(k) record. The listed applicant is Micronet Medical, Inc.. It received FDA 510(k) clearance on 2001-07-16 under 510(k) number K010008. 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 AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX?

AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX is a medical device that received FDA 510(k) clearance on 2001-07-16. The listed applicant is Micronet Medical, Inc.. The 510(k) number is K010008.

When did AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX receive FDA 510(k) clearance?

AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX received FDA 510(k) clearance on 2001-07-16, under 510(k) number K010008.

Who is the listed applicant for AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX?

The FDA 510(k) record lists Micronet Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX?

The FDA product code for AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX is GZB.

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Official Source

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

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