FDA applicant
Alesi Surgical, Ltd.
FDA records 7 decisions for Alesi Surgical, Ltd. (Cardiff, GB) from 2016 to 2024: 6 510(k) clearances and 1 De Novo grant. All are in product code PQM (Surgical Smoke Precipitator). Its devices cite 11 predicates, 7 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Alesi Surgical Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alesi Surgical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Alesi Surgical, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report