PC COATED FLUOROPLASTIC VENT TUBES

• K Number: K000801
• Device Name: PC COATED FLUOROPLASTIC VENT TUBES
• Manufacturer: GYRUS ENT L.L.C.
• Date Cleared: 2000-06-19 ( 98 days)
• Product Code: ETD
• Regulation Number: 874.3880
• Type: Traditional
• Panel: Ear Nose & Throat
• Reference & Predicate Devices: N/A
• Predicate For: K062672

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 874.3880 Tympanostomy tube.

(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.