21 CFR § 876.4530 - Gastroenterology-urology fiberoptic retractor.

---
identifier: "/us/cfr/t21/s876.4530"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 876.4530 - Gastroenterology-urology fiberoptic retractor."
title_number: 21
title_name: "Food and Drugs"
section_number: "876.4530"
section_name: "Gastroenterology-urology fiberoptic retractor."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "876"
part_name: "GASTROENTEROLOGY-UROLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "48 FR 53023, Nov. 23, 1983, unless otherwise noted."
cfr_part: "876"
---


# 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.

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