Panels › General, Plastic Surgery › Product code QAU · Class 2
Hemostatic Device For Endoscopic Gastrointestinal Use
Regulation 878.4456
3510(k)s in 12 months (12 all time)
1recalls in 12 months (8 all time)
4recalls that name a 510(k)
Top companies in QAU
| Company | 510(k)s | Recalls |
|---|---|---|
| Wilson-Cook Medical, Inc. | 3 | 8 |
| 3-D Matrix, Inc. | 3 | 0 |
| 3-D Matrix Europe SAS | 2 | 0 |
| Nextbiomedical Co., Ltd. | 2 | 0 |
| Endoclot Plus Co., Ltd. | 1 | 0 |
| Hemostasis, LLC | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 3, 2026 | K261503 | PuraStat GI 3-D Matrix, Inc. | QAU |
| Jun 2, 2026 | K253302 | Hemospray Endoscopic Hemostat (HEMO-[X]) Wilson-Cook Medical, Inc. | QAU |
| Jan 7, 2026 | K253924 | PuraStat 3-D Matrix Europe SAS, FR | QAU |
| Nov 27, 2024 | K240994 | Nexpowder Nextbiomedical Co., Ltd., KR | QAU |
| Oct 22, 2024 | K242250 | PuraStat 3-D Matrix Europe SAS, FR | QAU |
| Jul 26, 2024 | K234131 | Resolv Endoscopic Hemostat System Hemostasis, LLC | QAU |
| Feb 28, 2023 | K222481 | PuraStat 3-D Matrix, Inc. | QAU |
| Sep 16, 2022 | K202929 | Nexpowder Nextbiomedical Co., Ltd., KR | QAU |
| Jun 25, 2021 | K210098 | PuraStat-GI 3-D Matrix, Inc. | QAU |
| Jan 29, 2021 | K190677 | EndoClot Endoclot Plus Co., Ltd., CN | QAU |
| Jun 10, 2020 | K200972 | Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc. | QAU |
| May 7, 2018 | DEN170015 | Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc. | QAU |
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