FDA applicant
Angle Europe, Ltd.
FDA records 1 decision for Angle Europe, Ltd. (Guildford, GB) in 2022: 1 De Novo grant. All are in product code QSA (Circulating Tumor Cell (Ctc) Enrichment Device). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Angle Europe, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2022high 1 (2022) · low 0 (2023)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Angle Europe, 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