Blom-Singer Duckbill Voice Prosthesis

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K800563 ↗

FDA Product Code

EWL

Device Class

Class II

Regulation

21 CFR Part 874.3730

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Fome-Cuf-Wire Re-Enforced, Aire-Cuf Wire

  Class II

  FDA 510(k) K792035 Active Cleared 26 Oct 1979

• Aire-Cuf Polyester Re-Enforced Endotracheal Tube

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  FDA 510(k) K872366 Active Cleared 17 Aug 1987

• Fome-Cuf Pvc

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• Fome-Cuf and Aire Cuf Tracheostomy Tubes

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• Bivona Nasal Turbinate Stent

  Class I

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• Bivona Carden Intermittent Jetting Device

  Class II

  FDA 510(k) K895946 Active Cleared 9 Jan 1990

See all devices from Bivona Medical Technologies →