510(k) Report

FDA applicant

Manico

Walker, MI1 decision1985–19850 recalls

FDA records 1 decision for Manico (Walker, MI) in 1985: 1 510(k) clearance. All are in product code FEJ (Attachment, Binocular, For Endoscope). 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, gastroenterology and urology panel, where it files most

How often FDA has decided Manico’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Manico since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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