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Found 8 results
510(k) Data Aggregation
K Number
K071048Device Name
RUBICOR MAGIC BREAST BIOPSY DEVICE, MODEL 31537
Manufacturer
Date Cleared
2007-05-15
(32 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.
The Rubicor Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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
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K Number
K070275Device Name
FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE
Manufacturer
Date Cleared
2007-03-09
(39 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rubicor Flexible Loop Electrosurgical Electrode is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses. It is also intended to be used to cut soft tissue.
The Rubicor Flexible Loop Electrosurgical Electrode is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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
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K Number
K053151Device Name
RUBICOR MAGIC BREAST BIOPSY DEVICE
Manufacturer
Date Cleared
2005-11-18
(8 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rubicor Magic ™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.
The Rubicor Magic ™ Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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 Rubicor Magic Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes an 8 cm long, 10 gauge, stainless steel coring cannula and a sharp stylet that runs through the center of the cannula and extends from its distal end. The handle of the device contains an actuation button, two indicator lights, a removable sample collection chamber, a drive mechanism for advancing and rotating the coring cannula and transporting the core specimen to the collection chamber, a DC motor, and a 9 V battery.
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K Number
K052506Device Name
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108
Manufacturer
Date Cleared
2005-10-06
(23 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EnCapsule Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.
The EnCapsule Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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
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K Number
K032584Device Name
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30629
Manufacturer
Date Cleared
2003-09-17
(27 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.
The EnCapsule Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed 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
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K Number
K030049Device Name
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
Manufacturer
Date Cleared
2003-01-29
(23 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.
The Rubicor EnCapsule™ Breast Biopsy Device is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with a partial or complete removal of the imaged abnormality.
The extent of histological 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
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K Number
K023601Device Name
RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
Manufacturer
Date Cleared
2002-11-19
(22 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rubicor EnCapsule™ Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor EnCapsule™ Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
Device Description
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K Number
K020047Device Name
RUBICOR BREAST BIOPSY DEVICE
Manufacturer
Date Cleared
2002-04-05
(88 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
RUBICOR MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rubicor Breast Biopsy Device is intended for diagnostic sampling of breast tissue during breast biopsy procedure. The Rubicor Breast Biopsy Device is to be used for diagnostic purposes only and is not intended for therapeutic uses.
Device Description
Rubicor Breast Biopsy Device
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