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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)
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Top companies in QAU

Company510(k)sRecalls
Wilson-Cook Medical, Inc.38
3-D Matrix, Inc.30
3-D Matrix Europe SAS20
Nextbiomedical Co., Ltd.20
Endoclot Plus Co., Ltd.10
Hemostasis, LLC10
DateFirm and productCodeLinked 510(k)
Sep 16, 2026Wilson-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		 QAUK253302
Dec 2, 2024Wilson-Cook Medical Inc.
Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat, REF G24663, 2.8 cm, sterile.
Open, Classified		 QAUNone listed
Oct 16, 2024Wilson-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		 QAUK200972
Jun 21, 2023Wilson-Cook Medical Inc.
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
Open, Classified		 QAUK200972
Jun 21, 2023Wilson-Cook Medical Inc.
Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
Open, Classified		 QAUK200972
Feb 4, 2020Wilson-Cook Medical Inc.
HEMO-10 Hemospray Endoscopic Hemostat
Terminated		 QAUNone listed
Feb 4, 2020Wilson-Cook Medical Inc.
HEMO-7 Hemospray Endoscopic Hemostat
Terminated		 QAUNone listed
Jul 24, 2019Wilson-Cook Medical Inc.
Hemospray Endoscopic Hemostat
Terminated		 QAUNone listed

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