Hicut Highspeed Instrument

FDA 510(k) K130755 · Adeor Medical AG

Substantially Equivalent

510(k) numberK130755

Submission

Device name
Hicut Highspeed Instrument
Applicant
Adeor Medical AG
Pullach, DE
Received
March 19, 2013
Decision date
June 27, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 882.4310
Specialty
Neurology

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Questions and answers

When was Hicut Highspeed Instrument cleared by the FDA?

Hicut Highspeed Instrument (K130755) received a 510(k) decision of Substantially Equivalent on June 27, 2014, 465 days after the submission was received.

What is the product code of K130755?

The FDA product code is HBE – Drills, Burrs, Trephines & Accessories (Simple, Powered), a Class II (moderate risk) device regulated under 21 CFR 882.4310.