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Provox LaryButton Sizer Kit

Atos Medical AB · Model 7690 · UDI-DI 07331791002779

KAC Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

The Provox LaryButton Sizer Kit is intended for use by the prescribing clinician to determine the size(s) of LaryButton that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing clinician who has read the LaryButton 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 LaryButtons are intended for the sizing procedure only. After the correct size(s) have been determined a new LaryButton(s) shall be prescribed to the patient for actual 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.