Triton Canister System— 510(k) K142801
Substantially EquivalentGauss Surgical, Inc.,
FDA 510(k) clearance K142801 for Triton Canister System, Substantially Equivalent on 2015-03-12. Applicant: Gauss Surgical, Inc.,. Device class: 2.
Clearance details
- Applicant
- Gauss Surgical, Inc.,
- Product code
- Code PBZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.2750
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Altos, CA, US
Recent devices under product code PBZ
view allMore clearances from Gauss Surgical, Inc.,
view allRecalls naming K142801
K-number listed on FDA's recall record- Z-1184-2023 — 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.
- Z-1185-2023 — 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.
- Z-1186-2023 — Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
- Z-1402-2022 — 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 of blood loss. Used with blood bearing canisters and accessories.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142801.
Data sourced from openFDA. This site is unofficial and independent of the FDA.