510(k) Report

FDA applicant

Celon AG Medical Instruments

Teltow, DE2 decisions2003–20081 recall

FDA records 2 decisions for Celon AG Medical Instruments (Teltow, DE) from 2003 to 2008: 2 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 8 predicates, 0 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, general and plastic surgery panel, where it files most

How often FDA has decided Celon AG Medical Instruments’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2011

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

Class I Class II/III not classified

FIG. 1 — Celon AG Medical Instruments by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Celon AG Medical Instruments’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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K032838Celon Ent SystemCelon AG Medical Instruments · 20033cite it
  • K073207Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 20083cite it

What has FDA decided for it lately?

  • K073207Olympus Esg-100, Model WB991046; Olympus Afu-100, Model WB950167Celon AG Medical Instruments · 20081 recall
  • K032838Celon Ent SystemCelon AG Medical Instruments · 2003

All 2 as Celon AG Medical Instruments →

What has been recalled?

1 recall linked to its devices; the latest:

  • K073207Olympus Electrosurgical Unit. The Olympus Electrosurgical Unit (ESG-100) is used in…Nov 28, 2011