Skip to content

Cordis Disposable ICP Pressure Transducer

by Cordis Corp.

510(k) K940648

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 · Traditional NumberK940648 Date1 Mar 1995ClearedStatusActive

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  • Withdrawn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
GWM
Device Class
Class II
Regulation
21 CFR Part 882.1620
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

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

This device is a disposable intracranial pressure (ICP) pressure transducer used for monitoring intracranial pressure. It is a Class 2 medical device in the Neurology specialty with product code GWM.

It was cleared by the FDA through the Traditional 510(k) pathway under K940648, with a decision date of March 1, 1995. The device is supplied as a single-use, sterile transducer and is intended for use in clinical settings requiring intracranial pressure monitoring.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →