510(k) Report

FDA applicant

Madison Polymeric Engineering

Wallingford, CT2 decisions1997–19970 recalls

FDA records 2 decisions for Madison Polymeric Engineering (Wallingford, CT) in 1997: 2 510(k) clearances. Most are in product codes FRG (Wrap, Sterilization) and GEI (Electrosurgical, Cutting & Coagulation &…). 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 hospital panel, where it files most

How often FDA has decided Madison Polymeric Engineering’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Madison Polymeric Engineering since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Madison Polymeric Engineering 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?

  • FRGWrap, Sterilization1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K964256Cygnus Instrument ProtectorsMadison Polymeric Engineering · 1997
  • K965086Cygnus Electrosurgical Tip CleanerMadison Polymeric Engineering · 1997

All 2 as Madison Polymeric Engineering →