§ 876.1080. Gastroenterology-urology accessories to a biopsy instrument.
94 words·~1 min read·
/us/cfr/t21/s§ 876.1080·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A gastroenterology-urology accessory to a biopsy instrument is an accessory used to remove a specimen of tissue for microscopic examination by cutting or aspiration. This generic type of device includes a syringe for specimen aspiration and a biopsy channel adaptor. This device does not include accessories to biopsy instruments used in other medical specialty areas.
(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. [84 FR 14869, Apr. 12, 2019]