FDA applicant
Microsulis Medical Limited
FDA records 3 decisions for Microsulis Medical Limited (Denmead Hampshire, GB) from 2003 to 2012: 2 510(k) clearances and 1 original PMA approval. Most are in product codes NEY (System, Ablation, Microwave And Accessories) and MNB (Device, Thermal Ablation, Endometrial). Its devices cite 1 predicate, 1 of them its own earlier devices. 6 recalls are linked to its devices.
FDA’s records also spell it “Microsulis Medical , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Microsulis Medical Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2026 so far, outlined.
Recalls per year
6in 2017
Class I Class II/III not classified
Planning a device like Microsulis Medical Limited’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) ReportOther applicant names beginning “Microsulis”
FDA records each applicant name separately; these may or may not be the same firm.