510(k) K193137 ยท GCJ Laparoscope, General & Plastic Surgery
EASYGRIP FLO-41 Precision MIS Delivery System
| Applicant | Baxter Healthcare Corportation, Round Lake IL, US |
| Decision | Substantially Equivalent, Jan 8, 2020 |
| Received | Nov 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 15, 2021 | Baxter Healthcare Corporation EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar. Terminated |
GCJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.