510(k) Report

FDA applicant

Medinvents

Hasselt, Limburg, BE2 decisions2006–20081 recall

FDA records 2 decisions for Medinvents (Hasselt, Limburg, BE) from 2006 to 2008: 2 510(k) clearances. All are in product code KNW (Instrument, Biopsy). Its devices cite 7 predicates, 1 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 Medinvents’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 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medinvents’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?

  • KNWInstrument, Biopsy2decisions

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K060384Coramate/Spirotome SystemMedinvents · 20061cites it
  • K080095Coramate/Spirotome SystemMedinvents · 20081cites it

What has FDA decided for it lately?

  • K080095Coramate/Spirotome SystemMedinvents · 20081 recall
  • K060384Coramate/Spirotome SystemMedinvents · 20061 recall

All 2 as Medinvents →

What has been recalled?

1 recall linked to its devices; the latest:

  • K060384Spirotome" Soft-Tissue Biopsy Needle Set. The Spirotome Biopsy Needle Set includes a…Sep 26, 2014Class II