QAU — Hemostatic Device For Endoscopic Gastrointestinal Use Class II
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 |
|---|---|---|---|
| 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 |