MXP · Bone Particle Collector
Ear, Nose, Throat · 21 CFR 874.4800 · Class 1
Overview
| Product Code | MXP |
|---|---|
| Device Name | Bone Particle Collector |
| Regulation | 21 CFR 874.4800 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
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.
Cleared Devices (0)
No cleared devices on record.
