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Model 3487A Pisces Epidural Lead

FDA 510(k)

Class II (US FDA 510(k))

510(k) K885033

by Medtronic Vascular

Identifiers

510(k) Number
K885033 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 Model 3487A Pisces Epidural Lead is a spinal-cord stimulator designed for implanted use in pain relief applications. It is classified as a stimulator intended for epidural placement to modulate nerve signals and alleviate chronic pain through electrical stimulation.

This device is supplied sterile and intended for single-use implantation by trained medical professionals in clinical settings. It adheres to FDA 510(k) clearance (K885033) under product code GZB, with a regulatory classification as Class II under special controls. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What is the primary purpose of the Model 3487A Pisces Epidural Lead, and how does it work?

The Model 3487A Pisces Epidural Lead is designed for implanted use as a spinal-cord stimulator to provide pain relief. It works by delivering electrical stimulation to the epidural space of the spinal cord, modulating nerve signals to alleviate chronic pain. This is achieved through targeted electrical impulses that interfere with pain transmission pathways.

Is the Model 3487A Pisces Epidural Lead intended for reuse, or is it meant for single-use only?

The Model 3487A Pisces Epidural Lead is explicitly supplied sterile and intended for single-use implantation only. It is not designed for reuse, and adherence to sterile medical device protocols is required during handling and implantation to ensure patient safety.

What storage and handling requirements apply to the Model 3487A Pisces Epidural Lead?

Since the device is sterile and intended for single-use, it must be stored and handled according to standard sterile medical device protocols. This includes maintaining proper environmental conditions (e.g., clean, dry, and protected from contamination) until implantation. Always follow manufacturer guidelines to preserve sterility and functionality.

How is the regulatory status of the Model 3487A Pisces Epidural Lead determined, and what does that mean for clinicians?

The device holds FDA 510(k) clearance (K885033) under product code GZB, classified as Class II with special controls. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device and meets established safety and performance standards. Clinicians can rely on this clearance as evidence of regulatory scrutiny, though they should still follow approved clinical protocols for implantation.

Are there different sizes or models of the Model 3487A Pisces Epidural Lead, or is it available in a single configuration?

The provided data does not specify multiple sizes or distinct model variants for the Model 3487A Pisces Epidural Lead. However, the device is listed under multiple FEI numbers in the FDA registry, which may indicate variations in batch or lot tracking rather than physical size differences. For precise sizing or model-specific details, consult the manufacturer’s technical documentation or catalog.

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: MODEL 3487A PISCES EPIDURAL LEAD (K881491) — FDA 510 (k) | Innolitics, K881491 - MODEL 3487A PISCES EPIDURAL LEAD | FDA 510 (k), K885033 FDA 510 (k) - MODEL 3487A PISCES EPIDURAL LEAD, Model 3487a Pisces Epidural Lead 510(k) K881491 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Vascular

Sources (1)

  • FDA 510(k) K885033 24 fields · synced Sep 19, 2026