Identifiers
- 510(k) Number
- K032034 FDA 510(k)
- FDA Product Code
- GZB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5880 FDA 510(k)
- Regulation Number
- 882.5880 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ANS Axxess Percutaneous Lead is a stimulator, spinal-cord, implanted device intended for pain relief, classified under neurology. It is designed to be utilized as the lead component of spinal cord stimulation systems to aid in the management of chronic pain.
This device received FDA 510(k) clearance (K032034) on October 3, 2003, under regulation number 882.5880 and product code GZB. It is a class II device with traditional clearance, manufactured by Advanced Neuromodulation Systems, and its authorization is based on substantial equivalence to a predicate device.
Frequently asked questions
What is the ANS Axxess Percutaneous Lead used for?
The ANS Axxess Percutaneous Lead is intended as the lead component of spinal cord stimulation systems to aid in the management of chronic pain, functioning as an implanted stimulator for spinal-cord pain relief.
How is the ANS Axxess Percutaneous Lead supplied and is it reusable?
The device is supplied as an implanted lead component and is intended for single-use implantation; it is not designed for removal and reuse after implantation due to its role as a permanent or semi-permanent implant in neuromodulation therapy.
What regulatory pathway was used for the ANS Axxess Percutaneous Lead?
The ANS Axxess Percutaneous Lead received FDA 510(k) clearance under K032034 on October 3, 2003, based on substantial equivalence to a predicate device, and is classified as a class II device under regulation 882.5880 with product code GZB.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ANS AXXESS PERCUTANEOUS LEAD (K032034) — FDA 510(k) | Innolitics, PDF K032034 - Ans Axxess Percutaneous Lead, ANS AXXESS PERCUTANEOUS LEAD 510 (k) K032034 - FDA.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032034 | Class II | Active |
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Manufacturer
- Manufacturer
- Advanced Neuromodulation Systems
Sources (1)
- FDA 510(k) K032034 24 fields · synced Oct 1, 2026