Cleared Traditional

Cadwell Guardian

K230415 · Cadwell Industries, Inc. · Neurology
Aug 2023
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K230415 is an FDA 510(k) clearance for the Cadwell Guardian, a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Cadwell Industries, Inc. (Kennewick, US). The FDA issued a Cleared decision on August 17, 2023, 182 days after receiving the submission on February 16, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K230415 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2023
Decision Date August 17, 2023
Days to Decision 182 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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