FDA applicant
Creo Medical, Ltd.
FDA records 10 decisions for Creo Medical, Ltd. (Chepstow, GB) from 2017 to 2025: 10 510(k) clearances. Most are in product codes KNS (Unit, Electrosurgical, Endoscopic (With Or…) and NEY (System, Ablation, Microwave And Accessories). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 7 of them its own earlier devices. 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 Creo Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Creo Medical, 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) ReportOther applicant names beginning “Creo”
FDA records each applicant name separately; these may or may not be the same firm.