FDA Product Code
FDA Product Code QAU — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4456
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261503 | PuraStat GI | 3-D Matrix, Inc. | 2026-08-03 | Traditional | PDF ↗ |
| K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) | Wilson-Cook Medical, Inc. | 2026-06-02 | Traditional | PDF ↗ |
| K253924 | PuraStat | 3-D Matrix Europe SAS | 2026-01-07 | Special | PDF ↗ |
| K240994 | Nexpowder | Nextbiomedical Co., Ltd. | 2024-11-27 | Traditional | PDF ↗ |
| K242250 | PuraStat | 3-D Matrix Europe SAS | 2024-10-22 | Traditional | PDF ↗ |
| K234131 | Resolv Endoscopic Hemostat System | Hemostasis, LLC | 2024-07-26 | Traditional | PDF ↗ |
| K222481 | PuraStat | 3-D Matrix, Inc. | 2023-02-28 | Traditional | PDF ↗ |
| K202929 | Nexpowder | Nextbiomedical Co., Ltd. | 2022-09-16 | Traditional | PDF ↗ |
| K210098 | PuraStat-GI | 3-D Matrix, Inc. | 2021-06-25 | Traditional | PDF ↗ |
| K190677 | EndoClot | Endoclot Plus Co., Ltd. | 2021-01-29 | Traditional | PDF ↗ |
| K200972 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2020-06-10 | Traditional | PDF ↗ |
| DEN170015 | Hemospray Endoscopic Hemostat | Wilson-Cook Medical, Inc. | 2018-05-07 | Direct | — |
Product code QAU · Class II · General, Plastic Surgery. Data: openFDA.