Search Results
Found 2 results
510(k) Data Aggregation
K Number
K133702Device Name
PRESTO BREAST BIOPSY DEVICE
Manufacturer
Date Cleared
2014-02-28
(87 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
SONTINA MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Presto Breast Biopsy Device is intended for diagnostic sampling of breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.
The Presto 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 Presto Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes a stainless steel coring cannula with a razor edge and a stationary coil located within the coring cannula. The handle of the device contains an actuation button, a sample collection chamber, a drive mechanism for rotating the coring cannula and a DC power jack for a 12V input. A reusable, medical grade AC/DC power supply provides 12V to the disposable device. Depressing the button on the handle rotates the coring cannula - allowing the operator to core and transport tissue samples to the collection chamber. The device is used with a coaxial introducer. Actuating the partoff button mechanically adjusts the distal end of the coring cannula between a coring & partoff configuration.
Ask a Question
Ask a specific question about this device
K Number
K120440Device Name
PRESTO BREAST BIOPSY DEVICE
Manufacturer
Date Cleared
2012-05-17
(94 days)
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
SONTINA MEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Presto 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 Presto 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 Presto Breast Biopsy Device is a sterile, single-use percutaneous biopsy device. The working end of the device includes a stainless steel coring cannula with a razor edge and a stationary coil located within the coring cannula. The handle of the device contains an actuation button, a sample collection chamber, a drive mechanism for rotating the coring cannula and a DC power jack for a 12V input. A reusable, medical grade AC/DC power supply provides 12V to the disposable device. Depressing the button on the handle rotates the coring cannula - allowing the operator to core and transport tissue samples to the collection chamber. The device may be used with a coaxial introducer.
Ask a Question
Ask a specific question about this device
Page 1 of 1