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510(k) Data Aggregation
K Number
K972328Device Name
PERCUTANEOUS BREAST BIOPSY (PBB)
Manufacturer
UROTHEALTH SYSTEM, INC.
Date Cleared
1998-07-07
(379 days)
Product Code
KNW, FZX, KGE
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
UROTHEALTH SYSTEM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Diagnostic device used to obtain localized biopsies within breast tissue. Device is for diagnostics purpose only, it is not for therapeutic use. To be used with Percutaneous Breast Biopsy Instrument Accessories (Instrument Holder, Needle Holder, and Stop), which are attached to a stereotactic table and used in conjunction with stereotactic mammographic imaging systems.
Device Description
The PBB, a disposable breast biopsy device, is substantially equivalent to like devices in commercial distribution. These similar devices are marketed by United States Surgical Corporation (USSC), C.R. Bard, and Biopsys Medical. PBB, USSC, C.R. Bard and Biopsys devices are all used to obtain biopsies within breast tissue. These devices are used in conjunction with instrument accessories which are used to mount the devices on a stereotactic table. These devices are all used with stereotactic mammographic imaging systems. The PBB device is like the C.R. Bard and Biopsys devices in that they all remove a localized biopsy. These devices obturate up to the lesion, leaving intact the tissue in route to the target area. The PBB Instrument Accessories (Instrument Holder, and Stop) are similar to the instrument holding devices marketed by USSC, Biopsys, and C.R. Bard Magnum devices in that they are all reusable devices. All of these devices are used to mount their biopsy instrument on stereotactic tables. The PBB and similar devices on the market have components that are of similar materials that are well known and extensively used by device manufacturers. Materials which have patient contact consist of surgical stainless steel and thermoplastics. The PBB device is available with and without electrosurgery capability. The PBB device with electrosurgery capability and the USSC ABBI device both have monopolar electrosurgical capability. Both are equipped with a 4mm male plug to allow their use with standard monopolar electrosurgical generators.
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