Ipc Powerease System
FDA 510(k) K111520 · Medtronic Xomed, Inc.
510(k) numberK111520
Submission
- Device name
- Ipc Powerease System
- Applicant
- Medtronic Xomed, Inc.
Jacksonville, FL, US - Received
- June 2, 2011
- Decision date
- October 26, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Ipc Powerease System cleared by the FDA?
Ipc Powerease System (K111520) received a 510(k) decision of Substantially Equivalent on October 26, 2011, 146 days after the submission was received.
What is the product code of K111520?
The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.