PVV · Paracervical Anesthesia Kit
Obstetrics/Gynecology · 21 CFR 884.5100 · Class 2
Overview
| Product Code | PVV |
|---|---|
| Device Name | Paracervical Anesthesia Kit |
| Regulation | 21 CFR 884.5100 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
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).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
