21 CFR 876.1080
§ 876.1080 Gastroenterology-urology accessories to a biopsy instrument.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 876.1080, § 876.1080 Gastroenterology-urology accessories to a biopsy instrument, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90271
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.