510(k) Report

FDA applicant

Mgb Endoskopische Gerate GmbH (Berlin)

Berlin, DE4 decisions2003–20100 recalls

FDA records 4 decisions for Mgb Endoskopische Gerate GmbH (Berlin) (Berlin, DE) from 2003 to 2010: 4 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and FET (Endoscopic Video Imaging System/Component…). Its devices cite 4 predicates, 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, gastroenterology and urology panel, where it files most

How often FDA has decided Mgb Endoskopische Gerate GmbH (Berlin)’s devices, and how often a recall has named them.

FDA decisions per year

2in 2010

2010: 2
2007high 2 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Mgb Endoskopische Gerate GmbH (Berlin) 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?

  • GCJLaparoscope, General & Plastic Surgery2decisions
  • FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K093194MGB Disposable Retrieval Bag LapbagMgb Endoskopische Gerate GmbH (Berlin) · 20101cites it
  • K092584LaportMgb Endoskopische Gerate GmbH (Berlin) · 20101cites it

What has FDA decided for it lately?

  • K092584LaportMgb Endoskopische Gerate GmbH (Berlin) · 2010
  • K093194MGB Disposable Retrieval Bag LapbagMgb Endoskopische Gerate GmbH (Berlin) · 2010
  • K032544VP-1000; Med Cam 100; VP-3000A; Med Cam 300Mgb Endoskopische Gerate GmbH (Berlin) · 2003
  • K032545Endoscopic Light Source LS-3000X; LS-1800XG/Med Light X 180; LS-2500H/Med Light H 250Mgb Endoskopische Gerate GmbH (Berlin) · 2003

All 4 as Mgb Endoskopische Gerate GmbH (Berlin) →