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External Drainage Set

by Integra Neurosciences Implants S.A.

510(k) K032817

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK032817 Date6 Oct 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2910-2016 FDA Class II initiated 23 Aug 2016

    During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.

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  • Withdrawn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, 19 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 External Drainage Set is a medical device classified as a Shunt, Central Nervous System and Components, designed for the controlled drainage of cerebrospinal fluid (CSF) from the ventricular system of the brain. It facilitates the external diversion of CSF to manage conditions such as hydrocephalus by maintaining a low-pressure pathway for fluid removal.

This device is supplied as a sterile, single-use system and is intended for use in clinical settings such as hospitals or neurosurgical units. It includes components like extension tubing, a T-fitting, and a four-way stopcock, with no MRI safety restrictions noted. The set is regulated under FDA 510(k) clearance (K032817) and falls under Class II medical device classification, adhering to regulatory standards for neurological drainage applications.

Other devices from Integra Neurosciences Implants S.A.

Questions

AI-generated answers, 19 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 clinical conditions is this External Drainage Set primarily used to manage, and how does it work?

    The External Drainage Set is designed to manage conditions involving excess cerebrospinal fluid (CSF) in the brain, such as hydrocephalus. It creates a controlled, low-pressure pathway for CSF drainage from the ventricular system to an external collection system, allowing for careful monitoring and adjustment of fluid levels in clinical settings like hospitals or neurosurgical units.

  • Is this device reusable, or is it intended for single-use only? How does sterility factor into its use?

    The External Drainage Set is supplied as a sterile, single-use system. This ensures patient safety by preventing cross-contamination and maintaining sterility during use, which is critical in neurosurgical procedures where infection control is paramount.

  • What components are included in the External Drainage Set, and how are they connected?

    The set includes extension tubing, a T-fitting, and a four-way stopcock. These components work together to create a continuous pathway for CSF drainage from the brain’s ventricular system to an external collection device, allowing clinicians to regulate flow and monitor drainage.

  • Can this device be used in environments where MRI scans are performed, or are there restrictions?

    The External Drainage Set does not have any noted MRI safety restrictions, meaning it can be used in clinical settings where MRI scans are performed without additional safety concerns related to magnetic interference or imaging compatibility.

  • What regulatory pathway was followed for this device’s approval, and what class does it fall under?

    The External Drainage Set was cleared through the FDA’s 510(k) pathway (K032817) under a Special review, with a decision of Substantially Equivalent. It is classified as a Class II medical device, adhering to regulatory standards for neurological drainage applications.