Microsensor Intracranial Pressure Transducer

Q: What is the product code of K914479?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.

FDA 510(k) K914479 · Codman & Shurtleff, Inc.

Substantially Equivalent

510(k) numberK914479

Submission

Device name: Microsensor Intracranial Pressure Transducer
Applicant: Codman & Shurtleff, Inc.
Randolph, MA, US
Received: October 8, 1991
Decision date: March 7, 1994
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: GWM – Device, Monitoring, Intracranial Pressure
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.1620
Specialty: Neurology

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Questions and answers

When was Microsensor Intracranial Pressure Transducer cleared by the FDA?

Microsensor Intracranial Pressure Transducer (K914479) received a 510(k) decision of Substantially Equivalent on March 7, 1994, 881 days after the submission was received.

What is the product code of K914479?

The FDA product code is GWM – Device, Monitoring, Intracranial Pressure, a Class II (moderate risk) device regulated under 21 CFR 882.1620.