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510(k) Data Aggregation
K Number
K112763Device Name
MATRIXBRUSH ENDOMETRIAL SAMPLER
Manufacturer
POST OAK INNOVATIONS, INC.
Date Cleared
2012-06-18
(270 days)
Product Code
HFE
Regulation Number
884.1100Why did this record match?
Applicant Name (Manufacturer) :
POST OAK INNOVATIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MatrixBrush™ Endometrial Sampler is used to obtain endometrial cells for microscopic examination and/or for microbiology cultures.
Device Description
The MatrixBrush Endometrial Sampler is a sterile, single-use endometrial tissue sampling device. The MatrixBrush shaft is comprised of a spirally twisted stainless steel core covered by plastic with marked gradations. A nylon brush head at the distal end of the device collects a tissue sample and an atraumatic plastic bulb located on the extreme distal end protects the patient from penetration. A moveable plastic sheath overlies the brush head and device shaft.
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