Product Classification

• Device: system, vocal cord medialization
• Regulation Description: Ear, nose, and throat synthetic polymer material.
• Regulation Medical Specialty: Ear Nose & Throat
• Review Panel: Ear Nose & Throat
• Product Code: MIX
• Premarket Review: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1); Division of Dental and ENT Devices (DHT1B)
• Submission Type: 510(k)
• Regulation Number: 874.3620
• 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

• Vocal Fold Medialization Devices - Premarket Notification [510(k)] Submissions - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible