ANSPACH ANGLED MICRONOSE ATTACHMENT

• K Number: K002903
• Device Name: ANSPACH ANGLED MICRONOSE ATTACHMENT
• Manufacturer: THE ANSPACH EFFORT, INC.
• Date Cleared: 2000-10-24 ( 36 days)
• Product Code: HBE
• Regulation Number: 882.4310
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: K022942

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).