QAU — Hemostatic Device For Endoscopic Gastrointestinal Use Class II
FDA product code QAU covers "Hemostatic Device For Endoscopic Gastrointestinal Use", a Class II medical device regulated under 21 CFR 878.4456. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QAU
- Device Class
- Class II
- Regulation Number
- 878.4456
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253302 | wilson-cook medical | Hemospray Endoscopic Hemostat (HEMO-[X]) | June 2, 2026 |
| K253924 | 3-d matrix europe | PuraStat | January 7, 2026 |
| K240994 | nextbiomedical co | Nexpowder | November 27, 2024 |
| K242250 | 3-d matrix europe | PuraStat | October 22, 2024 |
| K234131 | hemostasis | Resolv Endoscopic Hemostat System | July 26, 2024 |
| K222481 | 3-d matrix | PuraStat | February 28, 2023 |
| K202929 | nextbiomedical co | Nexpowder | September 16, 2022 |
| K210098 | 3-d matrix | PuraStat-GI | June 25, 2021 |
| K190677 | endoclot plus co | EndoClot | January 29, 2021 |
| K200972 | wilson-cook medical | Hemospray Endoscopic Hemostat | June 10, 2020 |
| DEN170015 | wilson-cook medical | Hemospray Endoscopic Hemostat | May 7, 2018 |