Cleared Traditional

Arcus Head Fixation Frame

K191701 · Mri Interventions, Inc. · Neurology
Nov 2019
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K191701 is an FDA 510(k) clearance for the Arcus Head Fixation Frame, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on November 15, 2019, 143 days after receiving the submission on June 25, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K191701 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2019
Decision Date November 15, 2019
Days to Decision 143 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBL — Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4460

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