Home › Device types › QAU
Hemostatic Device For Endoscopic Gastrointestinal Use
FDA product code QAU · Class 2 · General, Plastic Surgery
10
Registered devices
1,077
Adverse events
7
Recalls
12
510(k) clearances
Devices with this code
Hemospray — COOK INCORPORATEDNexpowder — NEXTBIOMEDICAL CO., LTD.Hemospray — COOK INCORPORATEDEndoClot — EndoClot Plus Co.,Ltd.PuraStat — 3-D MATRIX EUROPEPuraStat (1mL) — 3-D MATRIX INC.Nexpowder — NEXTBIOMEDICAL CO., LTD.PuraStat (3mL) — 3-D MATRIX INC.Nexpowder — NEXTBIOMEDICAL CO., LTD.PuraStat — 3-D MATRIX EUROPE
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-31 | Wilson-Cook Medical Inc. | Specific lots of product have been manufactured with nonconforming raw materials resulting in the red activation knob cracking or breaking at the activation kno |
| 2024-08-29 | Wilson-Cook Medical Inc. | Specific lots of product have been manufactured with nonconforming raw materials. |
| 2023-05-22 | Wilson-Cook Medical Inc. | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and conse |
| 2023-05-22 | Wilson-Cook Medical Inc. | There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and conse |
| 2020-02-04 | Wilson-Cook Medical Inc. | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the ca |
| 2020-02-04 | Wilson-Cook Medical Inc. | Complaints that the handle and/or activation knob on Hemostat devices have cracked or broken when the device is activated. In some cases, this has caused the ca |
| 2019-07-24 | Wilson-Cook Medical Inc. | Potential for Hemospray device to be unable to spray powder due to misassembly of devices. |
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