(29 days)
The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature indicated for transendoscopic polypectomy and suction retrieval of lesions between 3mm and 7mm in size.
The dSnare Diminutive Polypectomy and Suction System is a non-diathermic device with a suction retrieval feature.
This document is a marketing authorization letter (510(k) clearance) from the FDA for a medical device called the "dSnare™ Diminutive Polypectomy and Suction System."
Crucially, this document does not contain any information regarding acceptance criteria, study details, or device performance metrics. It merely states that the device has been found substantially equivalent to a legally marketed predicate device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is strictly a regulatory clearance and does not include the technical details of device validation.
§ 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.