21 CFR 874.4800 — Bone Particle Collector
Ear, Nose, Throat (EN) · Part 874 Subpart E—Surgical Devices · § 874.4800
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.
Classification Rationale
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| MXP | Bone Particle Collector | 1 | 0 |
