eCFR Reference Browser

---

title: "21 CFR §874.4100"

source: "https://www.ecfr.gov/current/title-21/section-874.4100"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "874"

part_subject: "EAR, NOSE, AND THROAT DEVICES"

subpart_code: "E"

subpart_subject: "Surgical Devices"

section_number: "874.4100"

section_subject: "Epistaxis balloon."

cfr_reference: "21 CFR 874.4100"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(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.

(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.

§874.4100 - Epistaxis balloon.