{"data":{"id":"us/21-cfr-876.5100","jurisdiction":"us","citation":"21 CFR 876.5100","heading":"Suprapubic catheter accessories.","body":"(a) Identification. Suprapubic catheter accessories are manual devices that are used to facilitate the placement of a suprapubic catheter. This generic type of device includes the introducer, access dilator, and peel-away sheath.\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 F—Therapeutic 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":"92e99b3c9dbae5d36cdca0366182a32c1dcb52eb66149180cf85a167180a8355","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-876.5090","next":"us/21-cfr-876.5130"},"notice":"GroundRules: Original legal text. Not legal advice."}