← Product Code [HIO](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO) · K922960

# VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (K922960)

_Cameo, Inc. · HIO · Nov 5, 1992 · Obstetrics/Gynecology · SEKD_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K922960

## Device Facts

- **Applicant:** Cameo, Inc.
- **Product Code:** [HIO](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO.md)
- **Decision Date:** Nov 5, 1992
- **Decision:** SEKD
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1550
- **Device Class:** Class 1
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K922960](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HIO/K922960)

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