Cosgrove Depth Electrode Kit(Cdek)

Q: What is the product code of K961858?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.

FDA 510(k) K961858 · Radionics, Inc.

Substantially Equivalent

510(k) numberK961858

Submission

Device name: Cosgrove Depth Electrode Kit(Cdek)
Applicant: Radionics, Inc.
Burlington, MA, US
Received: May 14, 1996
Decision date: August 7, 1996
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HAW – Neurological Stereotaxic Instrument
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4560
Specialty: Neurology

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Questions and answers

When was Cosgrove Depth Electrode Kit(Cdek) cleared by the FDA?

Cosgrove Depth Electrode Kit(Cdek) (K961858) received a 510(k) decision of Substantially Equivalent on August 7, 1996, 85 days after the submission was received.

What is the product code of K961858?

The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.