Cleared Traditional

WiTOF

K243339 · Idmed · Anesthesiology
Jun 2025
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K243339 is an FDA 510(k) clearance for the WiTOF, a Stimulator, Nerve, Peripheral, Electric (Class II — Special Controls, product code KOI), submitted by Idmed (Marseille, FR). The FDA issued a Cleared decision on June 23, 2025, 241 days after receiving the submission on October 25, 2024. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2775.

Submission Details

510(k) Number K243339 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2024
Decision Date June 23, 2025
Days to Decision 241 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code KOI — Stimulator, Nerve, Peripheral, Electric
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.2775

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