CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 876—GASTROENTEROLOGY-UROLOGY DEVICES > SUBPART E—Surgical Devices (§876.4020 to §876.4890) > 876.4530—Gastroenterology-urology fiberoptic retractor.

876.4530—Gastroenterology-urology fiberoptic retractor.

(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.

Code of Federal Regulations

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