MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL

• K Number: K962163
• Device Name: MISTEN MEDICAL MISTEN MEDICAL SURGICAL DRILL
• Manufacturer: MISTEN MEDICAL CORP.
• Date Cleared: 1996-07-25 ( 51 days)
• Product Code: ERL
• Regulation Number: 874.4250
• Type: Traditional
• Panel: Ear Nose & Throat
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.