{"data":{"id":"us/21-cfr-876.4500","jurisdiction":"us","citation":"21 CFR 876.4500","heading":"Mechanical lithotriptor.","body":"(a) Identification. A mechanical lithotriptor is a device with steel jaws that is inserted into the urinary bladder through the urethra to grasp and crush bladder stones.\n(b) Classification. Class II (special controls). The device, when it is a biliary mechanical lithotripter, 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 E—Surgical 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":"16952a63017923f7604a8a49f588f5f3031eb16aa27ecb87c41380111f45cd05","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.4480","next":"us/21-cfr-876.4530"},"notice":"GroundRules: Original legal text. Not legal advice."}