510(k) Report

FDA applicant

Het Systems, LLC

Iselin, NJ3 decisions2011–20140 recalls

FDA records 3 decisions for Het Systems, LLC (Iselin, NJ) from 2011 to 2014: 3 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 8 predicates, 2 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, general and plastic surgery panel, where it files most

How often FDA has decided Het Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2011: 12012: 12014: 1
2011high 1 (2011) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Het Systems, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Het Systems, LLC’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 & Accessories3decisions

Whose devices does it build on?

Its devices cite 8 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 20141cites it
  • K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 20111cites it
  • K121085Het Bipolar Ligator SystemHet Systems, LLC · 20121cites it

What has FDA decided for it lately?

  • K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
  • K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012
  • K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011

All 3 as Het Systems, LLC →