SONO-VU US(TM), MODIFICATION
Device Facts
| Record ID | K921738 |
|---|---|
| Device Name | SONO-VU US(TM), MODIFICATION |
| Applicant | E-Z-Em, Inc. |
| Product Code | HIO · Obstetrics/Gynecology |
| Decision Date | Apr 27, 1992 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.1550 |
| Device Class | Class 1 |
Regulatory Classification
Identification
The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.
