FDA applicant

Surgidyne, Inc.

Eden Prairie, MN6 decisions1985–19890 recalls

FDA records 6 decisions for Surgidyne, Inc. (Eden Prairie, MN) from 1985 to 1989: 6 510(k) clearances. Most are in product codes BTA (Pump, Portable, Aspiration (Manual Or Powered)) and KDH (Catheter (Gastric, Colonic, Etc.), Irrigation…). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Surgidyne, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Surgidyne, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?