FDA applicant
Energist, Ltd.
FDA records 4 decisions for Energist, Ltd. (Swansea, GB) from 2006 to 2023: 4 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Energist Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Energist, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Energist, 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