21 C.F.R. · Food and Drugs
21 C.F.R. § 876.4020

Fiberoptic light ureteral catheter.

Title 21 C.F.R. ● ACTIVE Primary Source
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21 C.F.R. § 876.4020 — Fiberoptic light ureteral catheter.

§ 876.4020 Fiberoptic light ureteral catheter. (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. [48 FR 53023, Nov. 23, 1983, as amended at 84 FR 71813, Dec. 30, 2019]

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The regulatory text of 21 C.F.R. § 876.4020 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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