21 CFR 884.4500 — Hook, Destructive, Obstetrical
Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4500
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HDI | Hook, Destructive, Obstetrical | 2 | 0 | 3rd Party |
| HFZ | Craniotribe | 2 | 0 | 3rd Party |
| HGA | Cranioclast | 2 | 0 | 3rd Party |
| HHN | Cleidoclast | 2 | 0 | 3rd Party |
| KNB | Instrument, Destructive, Fetal, Obstetric | 2 | 1 | 3rd Party |
