# Hemostatic Device For Endoscopic Gastrointestinal Use
> **Product code: QAU** · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4456
## Classification
- **FDA Product Code:** QAU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 878.4456
- **Review panel:** SU
- **Medical specialty:** General, Plastic Surgery
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## Definition

Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.

## Market data
- **Cleared 510(k) submissions:** 10
- **Registered establishments:** 17
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=QAU)
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