510(k) Report

FDA applicant

Atlantic Surgical

Mchenry, IL3 decisions1977–19820 recalls

FDA records 3 decisions for Atlantic Surgical (Mchenry, IL) from 1977 to 1982: 3 510(k) clearances. Most are in product codes FON (Bag, Drainage, With Adhesive, Ostomy) and EXB (Collector, Ostomy). 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 Atlantic Surgical’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Atlantic Surgical since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Atlantic Surgical’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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