{"data":{"id":"us/21-cfr-876.1080","jurisdiction":"us","citation":"21 CFR 876.1080","heading":"Gastroenterology-urology accessories to a biopsy instrument.","body":"(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.\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 876—GASTROENTEROLOGY-UROLOGY DEVICES","Subpart B—Diagnostic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"493c924cb15d92fe0369f922dbf9fc86c9265655584125740519244060087434","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.1075","next":"us/21-cfr-876.1300"},"notice":"GroundRules: Original legal text. Not legal advice."}