21 CFR § 874.4800 - Bone particle collector.

---
identifier: "/us/cfr/t21/s874.4800"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 874.4800 - Bone particle collector."
title_number: 21
title_name: "Food and Drugs"
section_number: "874.4800"
section_name: "Bone particle collector."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "874"
part_name: "EAR, NOSE, AND THROAT 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: "51 FR 40389, Nov. 6, 1986, unless otherwise noted."
cfr_part: "874"
---


# 874.4800 Bone particle collector.

(a) *Identification.* A bone particle collector is a filtering device intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

(b) *Classification.* Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

[64 FR 10949, Mar. 8, 1999]