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Modification To Burr Hole Valve And Shunt System

by Integra Neurosciences Implants S.A.

510(k) K040201

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK040201 Date26 Feb 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JXG
Device Class
Class II
Regulation
21 CFR Part 882.5550
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Burr Hole Valve and Shunt System is a central nervous system component designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity. It functions as a flow-regulating valve system for the management of hydrocephalus.

This device is manufactured by Integra Neurosciences Implants S.A. and has received FDA 510k clearance. It is provided as a modification to the previously cleared Burr Hole Valve and Shunt System.

Other devices from Integra Neurosciences Implants S.A.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the Burr Hole Valve and Shunt System?

    This device is designed to manage hydrocephalus by acting as a flow-regulating valve system. It shunts cerebrospinal fluid from the brain's ventricles to an appropriate drainage site, such as the peritoneal cavity or the atrium of the heart.

  • Is this device a new product or a modification?

    This device is provided as a modification to the previously cleared Burr Hole Valve and Shunt System. It has received FDA 510k clearance as a substantially equivalent component for central nervous system applications.

  • What is the regulatory status of this shunt system?

    The device has received FDA 510k clearance under the neurology advisory committee. It is classified as a central nervous system shunt component, regulated under 21 CFR 882.5550.