# Appendiceal Scope And Accessories, Flexible
> **Product code: SHU** · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.1500
## Classification
- **FDA Product Code:** SHU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 876.1500
- **Review panel:** GU
- **Medical specialty:** Gastroenterology, Urology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

Inserted into the lower gastrointestinal lumen via the anus to provide visualization and therapeutic access to the appendix.  Navigation to the appendix may be accomplished by inserting the flexible appendiceal scope into the working channel of a colonoscope.  Does not include laparoscopes, telescopes, or other rigid scopes that are surgically inserted into the body through the abdominal wall.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 2
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SHU)
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