FDA applicant
Tristel Solutions Limited
FDA records 2 decisions for Tristel Solutions Limited (Snailwell, GB) from 2023 to 2025: 1 510(k) clearance and 1 De Novo grant. All are in product code QWS (Foam Or Gel Chemical Sterilant/High Level…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Tristel Solutions , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tristel Solutions Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Tristel Solutions Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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