510(k) K853472 ยท GAX Tourniquet, Nonpneumatic
FINGER TOURNIQUETTE
| Applicant | Joseph B. Marogil, Grand Rapids MI, US |
| Decision | Substantially Equivalent, Oct 10, 1985 |
| Received | Aug 20, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853472
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2021 | Mar-Med Co Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field. Terminated |
GAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.