Cleared Traditional

IonicRF Generator

K201610 · Abbott Medical · Neurology
Oct 2020
Decision
128d
Days
Class 2
Risk

About This 510(k) Submission

K201610 is an FDA 510(k) clearance for the IonicRF Generator, a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Abbott Medical (Plymouth, US). The FDA issued a Cleared decision on October 21, 2020, 128 days after receiving the submission on June 15, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K201610 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2020
Decision Date October 21, 2020
Days to Decision 128 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXD — Generator, Lesion, Radiofrequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4400

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