FDA applicant
Tools For Surgery, LLC
FDA records 4 decisions for Tools For Surgery, LLC (East Setauket, NY) from 2004 to 2025: 4 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and GDW (Staple, Implantable). Its devices cite 4 predicates, 1 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 Tools For Surgery, LLC’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 2007.
Planning a device like Tools For Surgery, LLC’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