# Barium Enema Kit
> **Product code: FCD** · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5210
## Classification
- **FDA Product Code:** FCD
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 876.5210
- **Review panel:** RA
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

## Market data
- **Cleared 510(k) submissions:** 2
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=FCD)
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