510(k) Report

FDA applicant

Derivadas Degasa S.A. DE C.V.

Palm Harobor, FL3 decisions1996–19960 recalls

FDA records 3 decisions for Derivadas Degasa S.A. DE C.V. (Palm Harobor, FL) in 1996: 3 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and LGF (Component, Cast). Its devices cite 1 predicate, 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, orthopedic panel, where it files most

How often FDA has decided Derivadas Degasa S.A. DE C.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Derivadas Degasa S.A. DE C.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Derivadas Degasa S.A. DE C.V. 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?

  • EFQGauze/Sponge, Internal2decisions
  • LGFComponent, Cast1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K961773Protec Sterile Gauze SpongeDerivadas Degasa S.A. DE C.V. · 1996
  • K960093Protec Roll GauzeDerivadas Degasa S.A. DE C.V. · 1996
  • K955320Protec Cotton Padding BandageDerivadas Degasa S.A. DE C.V. · 1996

All 3 as Derivadas Degasa S.A. DE C.V. →