510(k) Report

FDA applicant

Medisurg, Ltd.

Norristown, PA4 decisions2000–20071 recall

FDA records 4 decisions for Medisurg, Ltd. (Norristown, PA) from 2000 to 2007: 4 510(k) clearances. Most are in product codes NCR (Apparatus, Cutting, Radiofrequency…) and EKZ (Unit, Electrosurgical, And Accessories, Dental). Its devices cite 4 predicates, 3 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, ophthalmic panel, where it files most

How often FDA has decided Medisurg, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medisurg, Ltd. 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?

  • NCRApparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered3decisions
  • EKZUnit, Electrosurgical, And Accessories, Dental1decision

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 3 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.

  • K001498The Fugo BladeMedisurg, Ltd. · 20005cite it
  • K041019The Fugo Blade for GlaucomaMedisurg, Ltd. · 20041cites it
  • K050933Fugo Blade for Peripheral Iridotomy, Model M300Medisurg, Ltd. · 20051cites it

What has FDA decided for it lately?

  • K063468The Fugo Blade for DentistryMedisurg, Ltd. · 2007
  • K050933Fugo Blade for Peripheral Iridotomy, Model M300Medisurg, Ltd. · 2005
  • K041019The Fugo Blade for GlaucomaMedisurg, Ltd. · 2004
  • K001498The Fugo BladeMedisurg, Ltd. · 20001 recall

All 4 as Medisurg, Ltd. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K001498Fugo Blade Incising Tip Assembly. Incising tips to be used with the Fugo Blade M1000…Apr 28, 2006