HDN · Dilator, Cervical, Expandable
Obstetrics/Gynecology · 21 CFR 884.4250 · Class 3
Overview
| Product Code | HDN |
|---|---|
| Device Name | Dilator, Cervical, Expandable |
| Regulation | 21 CFR 884.4250 |
| Device Class | Class 3 |
| Review Panel | Obstetrics/Gynecology |
Identification
An expandable cervical dilator is an instrument with two handles and two opposing blades used manually to dilate (stretch open) the cervical os.
Classification Rationale
Class III (premarket approval).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
