21 CFR 884.4250 — Dilator, Cervical, Expandable
Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4250
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HDN | Dilator, Cervical, Expandable | 3 | 0 |
