KNB · Instrument, Destructive, Fetal, Obstetric
Obstetrics/Gynecology · 21 CFR 884.4500 · Class 2
Overview
| Product Code | KNB |
|---|---|
| Device Name | Instrument, Destructive, Fetal, Obstetric |
| 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890388 | CEPHALOTOMY SCISSORS | Kinetic Medical Products | Feb 13, 1989 | SESE |
Top Applicants
- Kinetic Medical Products — 1 clearance
