FDA applicant
Ark Surgical, Ltd.
FDA records 2 decisions for Ark Surgical, Ltd. (Nazareth, IL) from 2022 to 2025: 2 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and PMU (Containment System, Laparoscopic Power…). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ark Surgical”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ark Surgical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Ark Surgical, 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