(27 days)
The Manan™ Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
The Manan™ Pro-Mag Automatic Biopsy System is used to obtain multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.
The provided document is a 510(k) summary for the Manan™ Pro-Mag Automatic Biopsy System. It focuses on establishing substantial equivalence to previously marketed devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
Therefore, I cannot extract the requested information, which typically pertains to performance studies demonstrating the effectiveness and safety of a device against predefined metrics. This document is a regulatory filing, not a clinical or performance study report.
§ 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.