Profile: Siteselect Medical Technologies, Ltd offers SiteSelect® device. The SiteSelect device is an image guided/stereotactic excisional breast biopsy device allowing physicians to obtain a definitive diagnosis at the time of initial biopsy upon the first abnormal/suspicious mammographic findings. This minimally invasive breast biopsy device is recommended for high risk lesions where a complete histology is necessary to effectively treat patients affected by the breast disease. It requires a driver interface kit which allows the device to be mounted and calibrated to a specific stereotactic table. The interface kit is completely mechanical and noise-free providing tactile feedback to the physicians performing the procedure. Utilizing the interface also eliminates any use of electrocautery, RF ablation, motors and vacuum suctioning of the targeted tissue.
FDA Registration Number: 3004944996
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| • Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations. |
| • Biopsy Instruments (FDA Code: KNW / 876.1075) |
| • Electric Biopsy Forceps (FDA Code: KGE / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator. |
| • Instrument Surgical Guide (FDA Code: FZX / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
| • Invasive Breast Biopsy, Vacuum Assisted Device |
| • Minimally Invasive Breast Biopsy |