21 CFR 874.4350
§ 874.4350 Ear, nose, and throat fiberoptic light source and carrier.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 874.4350, § 874.4350 Ear, nose, and throat fiberoptic light source and carrier, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90239
- Permanent ID
ys:prov:90239@1- SHA-256
d5ebf2707b66ae6553ddadd10a85de4a18701d7a86fcb16e6f07b2dc6a1dc385
The hash is SHA-256 of this version's text, with every run of whitespace collapsed to a single space and the ends trimmed. The ID always leads back here, and checking it says whether the text you cited is still the current version.
Full text
(a) Identification. An ear, nose, and throat fiberoptic light source and carrier is an AC-powered device that generates and transmits light through glass of plastic fibers and that is intended to provide illumination at the tip of an ear, nose, or throat endoscope. Endoscopic devices which utilize fiberoptic light sources and carriers include the bronchoscope, esophagoscope, laryngoscope, mediastinoscope, laryngeal-bronchial telescope, and nasopharyngoscope.
(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 § 874.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.