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ANS SCS Accessory Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050922

by Advanced Neuromodulation Systems

Identifiers

510(k) Number
K050922 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)

An ANS SCS Accessory Kit is a device used during the implantation or revision of an ANS spinal cord stimulation (SCS) system. It is classified as a Stimulator, Spinal-Cord, Implanted (Pain Relief) device under FDA regulation number 882.5880.

The kit is supplied for use in clinical settings and is authorized under FDA 510(k) clearance K050922. It is intended as an accessory to the leads component of an implanted spinal cord stimulation system for the management of chronic pain management.

Frequently asked questions

What is the ANS SCS Accessory Kit used for?

The ANS SCS Accessory Kit is used during the implantation or revision of an ANS spinal cord stimulation (SCS) system. It serves as an accessory to the leads component of an implanted SCS system and is intended for the management of chronic pain. This kit supports the surgical procedure by providing necessary components to interface with or assist in placing the stimulator leads, but it does not deliver stimulation itself.

How is the ANS SCS Accessory Kit supplied and is it sterile or single-use?

The kit is supplied for use in clinical settings, indicating it is intended for use by healthcare professionals in a sterile environment such as an operating room. While the data does not explicitly state sterility or single-use status, its classification as an implanted system accessory and use during implantation or revision implies it is provided sterile and intended for single-use to maintain aseptic conditions and prevent infection during surgical procedures involving implanted neuromodulation devices.

What regulatory pathway was used for the ANS SCS Accessory Kit, and what does the clearance number indicate?

The ANS SCS Accessory Kit was authorized under FDA 510(k) clearance, specifically clearance number K050922, with a decision date of May 18, 2005. The 510(k) pathway means the device was found to be substantially equivalent to a legally marketed predicate device. The clearance type is listed as 'Special,' which may indicate a specialized review path, but the device does not carry de novo, PMA, or HDE status based on the provided data.

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 SCS ACCESSORY KIT (K050922) — FDA 510(k) | Innolitics, ANS SCS ACCESSORY KIT (K050922) — FDA 510(k) | Innolitics, Advanced Neuromodulation Systems, Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Advanced Neuromodulation Systems

Sources (1)

  • FDA 510(k) K050922 24 fields · synced Sep 25, 2026