MDT Navigable Brain Biopsy Cannula
FDA 510(k) K143241 · Izi Medical Products, LLC
510(k) numberK143241
Submission
- Device name
- MDT Navigable Brain Biopsy Cannula
- Applicant
- Izi Medical Products, LLC
Owings Mills, MD, US - Received
- November 12, 2014
- Decision date
- April 13, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MDT Navigable Brain Biopsy Cannula cleared by the FDA?
MDT Navigable Brain Biopsy Cannula (K143241) received a 510(k) decision of Substantially Equivalent on April 13, 2015, 152 days after the submission was received.
What is the product code of K143241?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.