(90 days)
The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.
The Speed-Cut is an automatic disposable biopsy instrument designed to take core samples from a variety of soft tissues including the liver, prostate and kidney.
This document is a 510(k) clearance letter for the Speed-Cut Automatic Biopsy System and only confirms the device's substantial equivalence to a predicate device. It does not contain the acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. 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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.