510(k) Report

FDA applicant

Derivados DE Gasa, S.A. DE C.V.

Palm Harobor, FL2 decisions1995–19950 recalls

FDA records 2 decisions for Derivados DE Gasa, S.A. DE C.V. (Palm Harobor, FL) in 1995: 2 510(k) clearances. Most are in product codes EFQ (Gauze/Sponge, Internal) and GDY (Gauze/Sponge, Internal, X-Ray Detectable). 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 Derivados DE Gasa, S.A. DE C.V.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Derivados DE Gasa, S.A. DE C.V. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Derivados DE Gasa, 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, Internal1decision
  • GDYGauze/Sponge, Internal, X-Ray Detectable1decision

What has FDA decided for it lately?

  • K955321Protec Gauze SpongeDerivados DE Gasa, S.A. DE C.V. · 1995
  • K955322Protec X-Ray Detectable Gauze SpongeDerivados DE Gasa, S.A. DE C.V. · 1995

All 2 as Derivados DE Gasa, S.A. DE C.V. →