# Tie, Dialysis
> **Product code: FKE** · Class I — Low Risk (general controls) · Gastroenterology, Urology · 21 CFR 876.5820
## Classification
- **FDA Product Code:** FKE
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 876.5820
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=FKE)
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