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Found 4 results
510(k) Data Aggregation
K Number
K970817Device Name
MICROMARK CLIP
Manufacturer
BIOPSYS MEDICAL, INC.
Date Cleared
1997-09-11
(189 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
BIOPSYS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location.
It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.
Device Description
The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers.
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K Number
K970565Device Name
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
Manufacturer
BIOPSYS MEDICAL, INC.
Date Cleared
1997-03-28
(43 days)
Product Code
KNW
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
BIOPSYS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.
Device Description
The Mammotome is comprised of a disposable needle instrument housing. The Mammotome probe may be used with imaging guidance (such as ultrasound, X-ray, and CT), and it may be either stereotactically mounted or hand held depending on physician preference and the type of tissue sampled. The disposable Mammotome probes are available in various sizes and lengths. The probe components include an outer trocar cannula and a sliding inner hollow coaxial cutter. The trocar cannula incorporates a distal sampling notch and a proximal notch which forms the tissue retrieval chamber. The sampling notch thumbwheel is used to manually turn and orientate the sampling notch as desired.
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K Number
K963015Device Name
SURGICAL STAPLE MARKER DEVICE (MODIFY)
Manufacturer
BIOPSYS MEDICAL, INC.
Date Cleared
1996-10-07
(74 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
BIOPSYS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.
Device Description
The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments.
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K Number
K960019Device Name
RETRACTOR ARM CLAMP
Manufacturer
BIOPSYS MEDICAL, INC.
Date Cleared
1996-02-09
(38 days)
Product Code
FWZ
Regulation Number
878.4950Why did this record match?
Applicant Name (Manufacturer) :
BIOPSYS MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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