{"data":{"id":"us/21-cfr-874.4100","jurisdiction":"us","citation":"21 CFR 874.4100","heading":"Epistaxis balloon.","body":"(a) Identification. An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.\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 § 874.9.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 874—EAR, NOSE, AND THROAT 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":"c6f33ad6a5197d9157daebcb6f7fe6d92a031b93f63219adf3c062f9aa676eb7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-874.3950","next":"us/21-cfr-874.4140"},"notice":"GroundRules: Original legal text. Not legal advice."}