FDA applicant
Surgipath
FDA records 12 decisions for Surgipath (Mchenry, IL) from 1981 to 1982: 12 510(k) clearances. Most are in product codes HZJ (Stain, Papanicolau) and HYJ (Hematoxylin). 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 Surgipath’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Surgipath since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Surgipath’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) ReportOther applicant names beginning “Surgipath”
FDA records each applicant name separately; these may or may not be the same firm.