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510(k) Data Aggregation
K Number
K102756Device Name
SURECORE BIOPSY DEVICE
Manufacturer
Date Cleared
2011-11-29
(432 days)
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
CHEST INNOVATIONS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Chest Innovations' SureCore™ Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.
Device Description
The SureCore™ Biopsy Device is an electrosurgical breast tissue biopsy device that is shipped sterile and intended for single use.
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