Skip to content

Panje Voice Prosthesis

by Xomed, Inc. 510(k)

Active United States

510(k) K810020

Overview

The Panje Voice Prosthesis is a Prosthesis, Laryngeal (Taub) designed for patients who have undergone laryngectomy. It is an artificial device, typically constructed from silicone, that restores speech function by creating an airway between the trachea and esophagus. This enables patients to produce sound through airflow manipulation, facilitating communication after the removal of the larynx. Its primary purpose is to aid vocal rehabilitation by providing a reliable pathway for speech generation.

This device is supplied as a single-use, sterile prosthesis intended for surgical implantation by qualified medical professionals. It is classified under FDA 510(k) clearance (K810020) and falls under Device Class II, regulated under CFR 21 Part 874.3730. The Panje Voice Prosthesis is available in specific reference codes (e.g., PVP-06) and is designed for use in otolaryngology settings. Storage and handling must adhere to sterile medical device protocols to ensure patient safety and device integrity.

AI-generated from registry data, 20 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK810020 Date5 Feb 1981ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
EWL
Device Class
Class II
Regulation
21 CFR Part 874.3730
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Xomed, Inc.

See all devices from Xomed, Inc. →