FDA applicant
Emcision, Ltd.
FDA records 10 decisions for Emcision, Ltd. (London, Uk, GB) from 2005 to 2018: 10 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). Its devices cite 11 predicates, 6 of them its own earlier devices. 6 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Emcision, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
1in 2023
Class I Class II/III not classified
Planning a device like Emcision, 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