FDA applicant
Via Surgical, Ltd.
FDA records 4 decisions for Via Surgical, Ltd. (Amirim, IL) from 2014 to 2021: 4 510(k) clearances. All are in product code GDW (Staple, Implantable). Since 2016 its 510(k)s took a median of 96 days from receipt to decision, against 205 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 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 Via Surgical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Via 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