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U.S. Department of Health and Human Services

Product Classification
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Device prosthesis, tracheal, preformed/molded
Regulation Description Tracheal prosthesis.
Definition The device is intended to provide support to weakened or constricting airway walls.
Physical State The device is tubular and traditionally made of silicone. Devices can range roughly from 6-14mm in diameter and have lengths as small as 20 mm to lengths as long as 150mm.
Technical Method The device functions independently providing physical support to the constricting airway.
Target Area The target area is the tracheobronchial tree
Regulation Medical Specialty General & Plastic Surgery
Review Panel Anesthesiology
Product CodeNWA
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Anesthesia, Respiratory, and Sleep Devices (DHT1C)
Submission Type 510(k)
Regulation Number 878.3720
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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