21 CFR 884.5100 — Set, Anesthesia, Paracervical

Obstetrics/Gynecology (OB) · Part 884 Subpart F—Obstetrical and Gynecological Therapeutic Devices · § 884.5100

Identification

An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
HEESet, Anesthesia, Paracervical293rd Party
HEGSet, Anesthesia, Pudendal203rd Party
KNESet, Anesthesia, Obstetric223rd Party
PVUObstetrical Anesthesia Kit20
PVVParacervical Anesthesia Kit20
PVWPudendal Anesthesia Kit20
Innolitics

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