KNE · Set, Anesthesia, Obstetric
Obstetrics/Gynecology · 21 CFR 884.5100 · Class 2
Overview
| Product Code | KNE |
|---|---|
| Device Name | Set, Anesthesia, Obstetric |
| Regulation | 21 CFR 884.5100 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K880988 | PUDENDAL/LOCAL ANESTESIA BLOCK TRAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 1, 1988 | SESE |
| K862358 | EPICATH | Hdc Corp. | Jul 7, 1986 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Hdc Corp. — 1 clearance
