510(k) Report

FDA applicant

Axcan Scientific Corp.

Walker, MI5 decisions1982–19840 recalls

FDA records 5 decisions for Axcan Scientific Corp. (Walker, MI) from 1982 to 1984: 5 510(k) clearances. Most are in product codes HFF (Aspirator, Endometrial) and HIG (Insufflator, Hysteroscopic). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Axcan Scientific Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Axcan Scientific Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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