510(k) K200972 ยท QAU Hemostatic Device For Endoscopic Gastrointestinal Use
Hemospray Endoscopic Hemostat
| Applicant | Wilson-Cook Medical, Inc., Winston-Salem NC, US |
| Decision | Substantially Equivalent, Jun 10, 2020 |
| Received | Apr 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.