510(k) Report

FDA applicant

Chek-Med Systems

Willington, CT3 decisions2000–20040 recalls

FDA records 3 decisions for Chek-Med Systems (Willington, CT) from 2000 to 2004: 3 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and NBG (Marker, Colon). 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 Chek-Med Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Chek-Med Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Chek-Med Systems 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?

  • GEHUnit, Cryosurgical, Accessories2decisions
  • NBGMarker, Colon1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K993951Spot Endoscopic MarkerChek-Med Systems · 20002cite it
  • K021387Polar WandChek-Med Systems · 20021cites it

What has FDA decided for it lately?

  • K041783Polar WandChek-Med Systems · 2004
  • K021387Polar WandChek-Med Systems · 2002
  • K993951Spot Endoscopic MarkerChek-Med Systems · 2000

All 3 as Chek-Med Systems →