Identifiers
- 510(k) Number
- K953742 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 Bifurcated Y-Extension is a connector interface accessory for spinal cord stimulation systems. It functions to connect two leads to a single implantable pulse generator or screening system. This device is classified as a Stimulator, Spinal-cord, Implanted for pain relief.
The Bifurcated Y-Extension is supplied as part of spinal cord stimulation systems and is used to facilitate the connection of multiple leads. It is a Class II device with special controls, cleared by the FDA under 510(k) number K953742. The device is regulated under product code GZB and regulation number 882.5880.
Frequently asked questions
What is the purpose of the Bifurcated Y-Extension?
The Bifurcated Y-Extension is a connector interface accessory for spinal cord stimulation systems that allows two leads to be connected to a single implantable pulse generator or screening system, facilitating pain relief treatment.
How is the Bifurcated Y-Extension supplied?
The Bifurcated Y-Extension is supplied as part of spinal cord stimulation systems and is designed to facilitate the connection of multiple leads to a single pulse generator.
What is the regulatory classification of the Bifurcated Y-Extension?
The Bifurcated Y-Extension is classified as a Class II device with special controls, cleared by the FDA under 510(k) number K953742, and is regulated under product code GZB and regulation number 882.5880.
What is the Bifurcated Y-Extension used for?
The Bifurcated Y-Extension is specifically designed for spinal cord stimulation systems to connect two leads to a single implantable pulse generator or screening system for pain relief treatment.
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: BIFURCATED Y-EXTENSION (K953742) - FDA 510 (k), BIFURCATED Y-EXTENSION (K953742) — FDA 510 (k) | Innolitics, Bifurcated Y-extension 510 (k) K953742 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K953742 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K953742 24 fields · synced Sep 26, 2026