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510(k) Data Aggregation
K Number
K212079Device Name
TeesuVac Breast Biopsy Device Mark 1
Manufacturer
Date Cleared
2022-02-02
(215 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
TeesuVac ApS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TeesuVac Breast Biopsy Device Mark 1 is indicated to obtain percutaneous core biopsy specimens from soft tissue, and tumors of the breast. This product is intended for diagnostic use only, NOT therapy. 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 removing 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
TeesuVac Breast Biopsy Device Mark 1 is a sterile, tetherless vacuum-assisted handheld biopsy device intended to obtain percutaneous core biopsy specimens from soft tissue and tumors of the breast with ultrasound guidance. TeesuVac Breast Biopsy Device Mark 1 is intended for biopsy and diagnosis only. The device is battery-driven and for single-patient use. An unsterilized Battery Pack that comes with the biopsy device is applied using the sterile Battery Clip, stored in the tray containing the biopsy device. The device is fitted with a 14G needle set to obtain specimens from soft tissue and tumors. The device is for professional users only. The tissue harvested by TeesuVac Breast Biopsy Device Mark 1 is intended for diagnostic use only.
The cannula needle consists of two hollow cannulas, an inner cannula with a specimen chamber, and a sharp outer cutting cannula that extends at high speeds over the aperture to acquire targeted tissue specimens. During the shot, a vacuum pulls the tissue into the chamber, followed by moving the outer cutting cannula forward over the specimen chamber to cut the tissue and collect the specimen in the specimen chamber. The TeesuVac Breast Biopsy Device Mark 1 has two buttons: the Slider for loading and the Sampling button to perform the biopsy procedure.
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