21 CFR §884.4400
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
- (a)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.
- (b)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.