510(k) K142801 ยท PBZ Image Processing Device For Estimation Of External Blood Loss
Triton Canister System
| Applicant | Gauss Surgical, Inc.,, Los Altos CA, US |
| Decision | Substantially Equivalent, Mar 12, 2015 |
| Received | Sep 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142801
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2023 | Stryker Corporation Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 2L
Catalog Number: FG 12010.
Intended adjunct in the estimation of blood loss. Open, Classified |
PBZ | None listed |
| Feb 27, 2023 | Stryker Corporation Finished Goods Box of 50 Inserts and Scanning Labels for Medivac Guardian 3L
Catalog Number: FG 12022.
Intended adjunct in the estimation of blood loss. Open, Classified |
PBZ | None listed |
| Feb 27, 2023 | Stryker Corporation Triton Canister Software
Catalog Number: GAUS-2.
Intended adjunct in the estimation of blood loss. Open, Classified |
PBZ | None listed |
| Jan 22, 2020 | Stryker Instruments Div. of Stryker Corporation Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part number 11032). A software application used to help estimation o Terminated |
PBZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.