Krupin Eye Valve with Disk

• 4 recalls, same reason

  • Terminated Z-0847-06 FDA Unclassified (pre-2012) ·initiated 12 Apr 2006
  • Terminated Z-0846-06 FDA Unclassified (pre-2012) ·initiated 12 Apr 2006
  • Terminated Z-0844-06 FDA Unclassified (pre-2012) ·initiated 12 Apr 2006
  • Terminated Z-0845-06 FDA Unclassified (pre-2012) ·initiated 12 Apr 2006

  Product may have deformed valves which would cause the valve not to operate properly.

510(k) Number

K905703 ↗

FDA Product Code

KYF

Device Class

Class II

Regulation

21 CFR Part 886.3920

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K853511 Active Cleared 19 Dec 1985

• Eliachar Modified Esophageal Stent

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• Hood Esophageal Prosthesis

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  FDA 510(k) K871244 Active Cleared 13 Apr 1987

• Acoustic Rhinometer

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See all devices from Hood Laboratories →