21 CFR 876.4020
§ 876.4020 Fiberoptic light ureteral catheter.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 876.4020, § 876.4020 Fiberoptic light ureteral catheter, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90296
- Permanent ID
ys:prov:90296@1- SHA-256
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Full text
(a) Identification. A fiberoptic light ureteral catheter is a device that consists of a fiberoptic bundle that emits light throughout its length and is shaped so that it can be inserted into the ureter to enable the path of the ureter to be seen during lower abdominal or pelvic surgery.
(b) Classification. Class II (special 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.