SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
FDA 510(k) K151536 · Mri Interventions, Inc.
510(k) numberK151536
Submission
- Device name
- SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
- Applicant
- Mri Interventions, Inc.
Irvine, CA, US - Received
- June 8, 2015
- Decision date
- July 8, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm cleared by the FDA?
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm (K151536) received a 510(k) decision of Substantially Equivalent on July 8, 2015, 30 days after the submission was received.
What is the product code of K151536?
The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.