510(k) Report

FDA applicant

Sudreca Surgical Dressings, Inc.

Mchenry, IL4 decisions1983–19830 recalls

FDA records 4 decisions for Sudreca Surgical Dressings, Inc. (Mchenry, IL) in 1983: 4 510(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 Sudreca Surgical Dressings, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sudreca Surgical Dressings, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sudreca Surgical Dressings, 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?

  • EFQGauze/Sponge, Internal2decisions
  • GDYGauze/Sponge, Internal, X-Ray Detectable1decision
  • BWPShoe And Shoe Cover, Conductive1decision

What has FDA decided for it lately?

  • K832172Gauze Sponge X-Ray Detectable-Sudreca Surgical Dressings, Inc. · 1983
  • K832173Gauze Sponge SterileSudreca Surgical Dressings, Inc. · 1983
  • K832174Gauze Sponge Non-SterileSudreca Surgical Dressings, Inc. · 1983
  • K831952Surgical Apparel Shoe CoversSudreca Surgical Dressings, Inc. · 1983

All 4 as Sudreca Surgical Dressings, Inc. →