FDA applicant
Cipher Surgical Limited
FDA records 2 decisions for Cipher Surgical Limited (Coventry, GB) from 2018 to 2022: 2 510(k) clearances. All are in product code OCX (Endoscopic Irrigation/Suction System). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Cipher Surgical, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Cipher Surgical Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Cipher Surgical 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) Report