(145 days)
The Multiple Biopsy System is intended to be used with a suction source to collect biopsy samples from the upper and lower gastrointestinal tract for microscopic examination.
Not Found
This is a letter for a 510(k) premarket notification for a "Multiple Biopsy System". This document does not contain information about acceptance criteria or a study proving device performance, as it is a regulatory clearance letter rather than a scientific study or performance report.
Therefore, I cannot extract the requested information from the provided text.
§ 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.