510(k) Report

FDA applicant

Intl. Medsurg Connection, Inc.

Schaumburg, IL2 decisions2005–20050 recalls

FDA records 2 decisions for Intl. Medsurg Connection, Inc. (Schaumburg, IL) in 2005: 2 510(k) clearances. Most are in product codes KKX (Drape, Surgical, Antimicrobial) and FYA (Gown, Surgical). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Intl. Medsurg Connection, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intl. Medsurg Connection, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • KKXDrape, Surgical, Antimicrobial1decision
  • FYAGown, Surgical1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052550Imc Surgical GownsIntl. Medsurg Connection, Inc. · 20053cite it
  • K050538Imc DrapesIntl. Medsurg Connection, Inc. · 20051cites it

What has FDA decided for it lately?

  • K052550Imc Surgical GownsIntl. Medsurg Connection, Inc. · 2005
  • K050538Imc DrapesIntl. Medsurg Connection, Inc. · 2005

All 2 as Intl. Medsurg Connection, Inc. →