510(k) Report

FDA applicant

Innovative Endoscopy Components, LLC

Ft. Lauderdale, FL3 decisions1999–20080 recalls

FDA records 3 decisions for Innovative Endoscopy Components, LLC (Ft. Lauderdale, FL) from 1999 to 2008: 3 510(k) clearances. Most are in product codes FET (Endoscopic Video Imaging System/Component…) and FAJ (Cystoscope And Accessories, Flexible/Rigid). Its devices cite 10 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 Innovative Endoscopy Components, LLC’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

No recall linked to its devices since 2007.

FIG. 1 — Innovative Endoscopy Components, LLC 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?

  • FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology1decision
  • FAJCystoscope And Accessories, Flexible/Rigid1decision
  • FGBUreteroscope And Accessories, Flexible/Rigid1decision

Whose devices does it build on?

Its devices cite 10 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K992983Baho Autoclavable CystoscopeInnovative Endoscopy Components, LLC · 19991cites it

What has FDA decided for it lately?

  • K080809Iec Medsight and MedbrightInnovative Endoscopy Components, LLC · 2008
  • K062707Rudolf Innoview Autoclavable Semi-Rigid Uretero-RenoscopeInnovative Endoscopy Components, LLC · 2006
  • K992983Baho Autoclavable CystoscopeInnovative Endoscopy Components, LLC · 1999

All 3 as Innovative Endoscopy Components, LLC →