510(k) Report

FDA applicant

World of Medicine Lemke GmbH

Cambridge, MA7 decisions2002–20031 recall

FDA records 7 decisions for World of Medicine Lemke GmbH (Cambridge, MA) from 2002 to 2003: 7 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GCT (Light Source, Endoscope, Xenon Arc). Its devices cite 14 predicates, 2 of them its own earlier devices. 1 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, gastroenterology and urology panel, where it files most

How often FDA has decided World of Medicine Lemke GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for World of Medicine Lemke GmbH since 2007.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — World of Medicine Lemke GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like World of Medicine Lemke GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GCJLaparoscope, General & Plastic Surgery4decisions
  • GCTLight Source, Endoscope, Xenon Arc3decisions

Whose devices does it build on?

Its devices cite 14 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 2 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.

  • K021717Endoscopic Light Source, Model XL300/L5World of Medicine Lemke GmbH · 20024cite it
  • K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 20031cites it
  • K020336Endoscopic Camera MC404/C3World of Medicine Lemke GmbH · 20021cites it
  • K014158Endoscopic Camera TC804/C4World of Medicine Lemke GmbH · 20021cites it
  • K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 20021cites it

What has FDA decided for it lately?

  • K024251SightfixWorld of Medicine Lemke GmbH · 2003
  • K023468Endoscopic Light Source XL180/L3World of Medicine Lemke GmbH · 2003
  • K021717Endoscopic Light Source, Model XL300/L5World of Medicine Lemke GmbH · 2002
  • K021456ER150/M2World of Medicine Lemke GmbH · 2002
  • K020889Endoscopic Light Source XL202/L3World of Medicine Lemke GmbH · 2002
  • K020336Endoscopic Camera MC404/C3World of Medicine Lemke GmbH · 2002
  • K014158Endoscopic Camera TC804/C4World of Medicine Lemke GmbH · 20021 recall

All 7 as World of Medicine Lemke GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K014158Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage…Sep 23, 2011