21 C.F.R. § 876.1080

Current through September 30, 2024
Section 876.1080 - Gastroenterology-urology accessories to a biopsy instrument
(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 .

21 C.F.R. §876.1080

84 FR 14869, Apr. 12, 2019
84 FR 14869, 5/13/2019