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Provox LaryTube Sizer Kit

Atos Medical AB · Model 7648 · UDI-DI 07331791005329

KAC Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The Provox LaryTube Sizer Kit is intended for use by the prescribing specialist to determine the size(s) of LaryTube that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing specialist who has read the LaryTube Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryTubes are intended for the sizing procedure only. After the correct size(s) have been determined, new LaryTube(s) shall be given to the patient for use.

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.