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510(k) Data Aggregation
K Number
K964634Device Name
ANOKRYO
Manufacturer
Date Cleared
1997-06-06
(199 days)
Product Code
Regulation Number
876.5450Why did this record match?
Product Code :
FFP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Dilation of the anal sphincter and canal for the relief of hemorrhoidal pain and itching, reduction of bleeding, and promotion of healing of inflamed hemorrhoidal tissues.
Device Description
The Anokryo Dilator consists of a narrow tapered shaft approximately 2.75 inch long and 0.5 inch wide. The hollow interior of the shaft is filled with hydroxyethylcellulose solution before the shaft is molded to a flange knob which serves as a handle The shaft and flange are composed of polyethylene. The device is supplied clean and non-sterile in a plastic storage container and a water-soluble lubricant gel. Prior to use, the rod is stored in its container for 1-2 hours and then moistened with the lubricant gel. A maximum low temperature of -15 degrees C is obtained and sustained for 10 minutes. The device is easily cleaned with detergent and water and stored in its container for reuse.
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