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510(k) Data Aggregation
K Number
K011488Device Name
SPIRABRUSH CX BIOPSY INSTRUMENT
Manufacturer
TRYLON CORP.
Date Cleared
2002-02-22
(283 days)
Product Code
HFB
Regulation Number
884.4530Why did this record match?
Product Code :
HFB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SpiraBrush Cx is intended for obtaining a biopsy of visible exocervical lesions for the purpose of obtaining a tissue diagnosis in women with intraepithelial disease. Tissue samples obtained by the SpiraBrush Cx biopsy instrument should be evaluated using a histologic technique.
Device Description
The SpiraBrush Cx is a biopsy instrument consisting of a sampling head and a handle. The sampling head is placed directly onto the exocervical lesion or cervical area to be biopsied, and rotated to collect a tissue sample. The head is then snapped off the handle and placed in a preservative solution for laboratory processing.
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