21 CFR 876.4530
§ 876.4530 Gastroenterology-urology fiberoptic retractor.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.4530, § 876.4530 Gastroenterology-urology fiberoptic retractor, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90308
- Permanent ID
ys:prov:90308@1- SHA-256
2af1ac78c93c5e3e84183e9c3fff77d02f8a27841e4418dbafa7198f67751395
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Full text
(a) Identification. A gastroenterology-urology fiberoptic retractor is a device that consists of a mechanical retractor with a fiberoptic light system that is used to illuminate deep surgical sites.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.