510(k) Report

FDA applicant

Lorrex Health Products

Secaucus, NJ16 decisions1993–19940 recalls

FDA records 16 decisions for Lorrex Health Products (Secaucus, NJ) from 1993 to 1994: 16 510(k) clearances. Most are in product codes GDY (Gauze/Sponge, Internal, X-Ray Detectable) and EFQ (Gauze/Sponge, Internal). 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 Lorrex Health Products’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Lorrex Health Products since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lorrex Health Products 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?

  • GDYGauze/Sponge, Internal, X-Ray Detectable9decisions
  • EFQGauze/Sponge, Internal6decisions
  • FLKThermometer, Clinical Mercury1decision

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K942070Lorrex Cover Sponges STERILE2'S and Non-SterileLorrex Health Products · 19941cites it

What has FDA decided for it lately?

  • K945553Round Stick Sponges, Flat Stick SpongesLorrex Health Products · 1994
  • K945866Cylindrical SpongeLorrex Health Products · 1994
  • K945333Kittner DissectorLorrex Health Products · 1994
  • K945606Triangular SpongesLorrex Health Products · 1994
  • K945335Cherry DissectorLorrex Health Products · 1994
  • K945332Rosebud DissectorLorrex Health Products · 1994
  • K945336Peanut DissectorLorrex Health Products · 1994
  • K945334Cherry Pit DissectorLorrex Health Products · 1994

All 16 as Lorrex Health Products →