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The Venus System

by Neuroscientific Corp.

510(k) K880773

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 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK880773 Date18 Aug 1988ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0186-05 FDA Unclassified (pre-2012) initiated 15 Sep 2004 on shared 510(k) K880773

    The firm established no medical device quality system, no established quality plan and no established quality procedures.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
GWL
Device Class
Class II
Regulation
21 CFR Part 882.1835
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Venus System is a physiological signal amplifier device used in neurology applications. It is designed to amplify physiological signals for diagnostic and monitoring purposes in neurological examinations.

The Venus System is supplied as a Class II medical device with FDA 510(k) clearance (K880773). It is manufactured by Neuroscientific Corp. and is not specified as single-use or reusable. The device is not indicated for MRI safety, and specific sizes are not provided in the data.

Other devices from Neuroscientific Corp.

Questions

AI-generated answers, 23 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 Venus System used for?

    The Venus System is a physiological signal amplifier device designed for diagnostic and monitoring purposes in neurological examinations. It amplifies physiological signals to aid clinicians in neurological assessments.

  • Is the Venus System single-use or reusable?

    The device data does not specify whether the Venus System is single-use or reusable. This information should be confirmed with the manufacturer, Neuroscientific Corp., for specific usage guidelines.

  • What regulatory approvals does the Venus System have?

    The Venus System is a Class II medical device with FDA 510(k) clearance (K880773) under the product code GWL. It is manufactured by Neuroscientific Corp. and is not indicated for MRI safety.

  • What sizes or models of the Venus System are available?

    The device data does not provide information about specific sizes or models of the Venus System. For detailed specifications regarding available configurations, contact Neuroscientific Corp. directly.