HDI · Hook, Destructive, Obstetrical
Obstetrics/Gynecology · 21 CFR 884.4500 · Class 2
Overview
| Product Code | HDI |
|---|---|
| Device Name | Hook, Destructive, Obstetrical |
| Regulation | 21 CFR 884.4500 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An obstetric fetal destructive instrument is a device designed to crush or pull the fetal body to facilitate the delivery of a dead or anomalous (abnormal) fetus. This generic type of device includes the cleidoclast, cranioclast, craniotribe, and destructive hook.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (0 of 0)
No cleared devices on record.
