Brain Biopsy Needle
FDA 510(k) K112094 · Ad-Tech Medical Instrument Corp
510(k) numberK112094
Submission
- Device name
- Brain Biopsy Needle
- Applicant
- Ad-Tech Medical Instrument Corp
Stoughton, WI, US - Received
- July 22, 2011
- Decision date
- April 24, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Brain Biopsy Needle cleared by the FDA?
Brain Biopsy Needle (K112094) received a 510(k) decision of Substantially Equivalent on April 24, 2012, 277 days after the submission was received.
What is the product code of K112094?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.