21 CFR 884.4400 — Forceps, Obstetrical
Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4400
Identification
An obstetric forceps is a device consisting of two blades, with handles, designed to grasp and apply traction to the fetal head in the birth passage and facilitate delivery.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HDA | Forceps, Obstetrical | 2 | 10 |
Special Controls
HDA — Forceps, Obstetrical
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.
eCFR
