FDA applicant
Seedling Enterprises., LLC
FDA records 4 decisions for Seedling Enterprises., LLC (Ayer, MA) from 2000 to 2001: 4 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 5 predicates, 0 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 Seedling Enterprises., LLC’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Seedling Enterprises., LLC since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Seedling Enterprises., 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