510(k) Report

FDA applicant

Vision Systems Group, A Division of Viking Systems

South Grafton, MA2 decisions2008–20100 recalls

FDA records 2 decisions for Vision Systems Group, A Division of Viking Systems (South Grafton, MA) from 2008 to 2010: 2 510(k) clearances. Most are in product codes FET (Endoscopic Video Imaging System/Component…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 3 predicates, 1 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 Vision Systems Group, A Division of Viking Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Vision Systems Group, A Division of Viking Systems by year, 2008–2026Sources: 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
  • GCJLaparoscope, General & Plastic Surgery1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K081585Endoscopy Video Camera SystemVision Systems Group, A Division of Viking Systems · 20081cites it

What has FDA decided for it lately?

  • K1018103DHJD Camera System ModelVision Systems Group, A Division of Viking Systems · 2010
  • K081585Endoscopy Video Camera SystemVision Systems Group, A Division of Viking Systems · 2008

All 2 as Vision Systems Group, A Division of Viking Systems →