(44 days)
Needle can be used for obtaining core and/or aspiration biopsies of various tissues (Prostate, lung, kidney, liver, spleen, thyroid, adrenals, abdominal soft tissue masses, breast). For Breast Biopsy this product is for diagnosis only-not for therapeutic use.
Automatic Cutting Needle
This document is a 510(k) clearance letter from the FDA for a medical device called the "Manan Automatic Cutting Needle." It indicates that the device has been found substantially equivalent to a predicate device already on the market.
However, the letter does not contain any information regarding specific acceptance criteria, study details, or performance data for the device. It primarily focuses on the regulatory clearance process and the device's classification.
Therefore, I cannot provide the requested information in the table or answer the specific questions about acceptance criteria and study details based on the provided text. The document is a regulatory approval letter, not a technical report or study summary.
§ 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.