Arcus Head Fixation Frame

FDA 510(k) K191701 · Mri Interventions, Inc.

Substantially Equivalent

510(k) numberK191701

Submission

Device name
Arcus Head Fixation Frame
Applicant
Mri Interventions, Inc.
Irvine, CA, US
Received
June 25, 2019
Decision date
November 15, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBL – Holder, Head, Neurosurgical (Skull Clamp)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4460
Specialty
Neurology

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Questions and answers

When was Arcus Head Fixation Frame cleared by the FDA?

Arcus Head Fixation Frame (K191701) received a 510(k) decision of Substantially Equivalent on November 15, 2019, 143 days after the submission was received.

What is the product code of K191701?

The FDA product code is HBL – Holder, Head, Neurosurgical (Skull Clamp), a Class II (moderate risk) device regulated under 21 CFR 882.4460.