MR Compatible Aspiration Kit

FDA 510(k) K181731 · Mri Interventions, Inc.

Substantially Equivalent

510(k) numberK181731

Submission

Device name
MR Compatible Aspiration Kit
Applicant
Mri Interventions, Inc.
Irvine, CA, US
Received
June 29, 2018
Decision date
November 20, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GWG – Endoscope, Neurological
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1480
Specialty
Neurology

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was MR Compatible Aspiration Kit cleared by the FDA?

MR Compatible Aspiration Kit (K181731) received a 510(k) decision of Substantially Equivalent on November 20, 2018, 144 days after the submission was received.

What is the product code of K181731?

The FDA product code is GWG – Endoscope, Neurological, a Class II (moderate risk) device regulated under 21 CFR 882.1480.