510(k) Report

FDA applicant

Surgipath

Mchenry, IL12 decisions1981–19820 recalls

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, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

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.

FIG. 1 — Surgipath by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Surgipath”

FDA records each applicant name separately; these may or may not be the same firm.