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Provox LaryTube 9/55

Atos Medical AB · Model 7607 · UDI-DI 07331791002175

KAC Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The Standard model is made for use with or without a voice prosthesis. The Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The standard model can be attached with a Provox TubeHolder or Provox LaryClips.

Recalls

Date	Firm	Reason
2006-12-15	Smiths Medical ASD, Inc.	The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.