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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | Wilson-Cook Medical Inc. Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT
Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU
Software Version: N/A
Product Description: Hemostatic Open, Classified |
QAU | K253302 |
| Dec 2, 2024 | Wilson-Cook Medical Inc. Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile. Open, Classified |
QAU | None listed |
| Oct 16, 2024 | Wilson-Cook Medical Inc. Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal Open, Classified |
QAU | K200972 |
| Jun 21, 2023 | Wilson-Cook Medical Inc. Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346 Open, Classified |
QAU | K200972 |
| Jun 21, 2023 | Wilson-Cook Medical Inc. Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663; Open, Classified |
QAU | K200972 |
| Feb 4, 2020 | Wilson-Cook Medical Inc. HEMO-10 Hemospray Endoscopic Hemostat Terminated |
QAU | None listed |
| Feb 4, 2020 | Wilson-Cook Medical Inc. HEMO-7 Hemospray Endoscopic Hemostat Terminated |
QAU | None listed |
| Jul 24, 2019 | Wilson-Cook Medical Inc. Hemospray Endoscopic Hemostat Terminated |
QAU | None listed |
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