510(k) Report

FDA applicant

Vectec

Fairfax, VA3 decisions2007–20130 recalls

FDA records 3 decisions for Vectec (Fairfax, VA) from 2007 to 2013: 3 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and FHO (Pneumoperitoneum Needle). Its devices cite 7 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2013

2007: 12011: 12013: 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 — Vectec 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • FHOPneumoperitoneum Needle1decision

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K071976Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 20072cite it

What has FDA decided for it lately?

  • K121370Vectec Disposable Pneumoperitoneum NeedleVectec · 2013
  • K103707Vectec Disposable Monopolar Connector CableVectec · 2011
  • K071976Vectec Disposable Trocars and Laparoscopic AccessoriesVectec · 2007

All 3 as Vectec →