21 CFR 884.4340 — Extractor, Vacuum, Fetal

Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4340

Identification

A fetal vacuum extractor is a device used to facilitate delivery. The device enables traction to be applied to the fetal head (in the birth canal) by means of a suction cup attached to the scalp and is powered by an external vacuum source. This generic type of device may include the cup, hosing, vacuum source, and vacuum control.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HDBExtractor, Vacuum, Fetal2303rd Party
OHCObstetrical Vacuum Delivery Kit20
Innolitics

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