510(k) Report

FDA applicant

Orbus Medical Technologies

Fort Lauderdale, FL8 decisions2001–20041 recall

FDA records 8 decisions for Orbus Medical Technologies (Fort Lauderdale, FL) from 2001 to 2004: 8 510(k) clearances. All are in product code FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 7 predicates, 6 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 Orbus Medical Technologies’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Orbus Medical Technologies since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Orbus Medical Technologies 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?

  • FGEStents, Drains And Dilators For The Biliary Ducts8decisions

Whose devices does it build on?

Its devices cite 7 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 6 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.

  • K023248Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 20034cite it
  • K023308Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 20033cite it
  • K033212Lifestent SDS Biliary EndoprosthesisOrbus Medical Technologies · 20032cite it
  • K041032Modification to Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 20041cites it
  • K040550Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 20041cites it
  • K041370Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 20041cites it

What has FDA decided for it lately?

  • K041370Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
  • K041032Modification to Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
  • K040550Lifestent SDS and XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 2004
  • K033212Lifestent SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003
  • K023308Lifestent SDS Biliary Endoprosthesis, Lifestent XL SDS Biliary EndoprosthesisOrbus Medical Technologies · 2003
  • K023121Lifestent Biliary EndoprosthesisOrbus Medical Technologies · 2003
  • K023248Lifestent LP SDS Biliary EndoprosthesisOrbus Medical Technologies · 20031 recall
  • K010107R Stent Biliary EndoprosthesisOrbus Medical Technologies · 2001

All 8 as Orbus Medical Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K023248The product is a stainless steel stent mounted on a PTA balloon delivery device. The…Mar 19, 2004