# Endoscopic Guidewire, Gastroenterology-Urology
> **Product code: OCY** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500
## Classification
- **FDA Product Code:** OCY
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.1500
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

## Market data
- **Cleared 510(k) submissions:** 43
- **Registered establishments:** 91
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=OCY)
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