V-Guide for Ventriculostomies
FDA 510(k) K141559 · Arc Surgical, LLC
510(k) numberK141559
Submission
- Device name
- V-Guide for Ventriculostomies
- Applicant
- Arc Surgical, LLC
Melbourne, FL, US - Received
- June 12, 2014
- Decision date
- February 27, 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 V-Guide for Ventriculostomies cleared by the FDA?
V-Guide for Ventriculostomies (K141559) received a 510(k) decision of Substantially Equivalent on February 27, 2015, 260 days after the submission was received.
What is the product code of K141559?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.