Code · CFR · Title 21 — Food and Drugs · Part 876 — Gastroenterology-Urology Devices · § 876.4530

§ 876.4530. Gastroenterology-urology fiberoptic retractor.

80 words·~1 min read·/us/cfr/t21/s§ 876.4530

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(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. [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 66 FR 38801, July 25, 2001]