FOD · Device, Occlusion, Umbilical
General Hospital · 21 CFR 880.5950 · Class 1
Overview
| Product Code | FOD |
|---|---|
| Device Name | Device, Occlusion, Umbilical |
| Regulation | 21 CFR 880.5950 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
An umbilical occlusion device is a clip, tie, tape, or other article used to close the blood vessels in the umbilical cord of a newborn infant.
Classification Rationale
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 § 880.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
