510(k) Report

FDA applicant

Surgical Innovations Group Plc

Leeds West Yorkshire, GB2 decisions2007–20101 recall

FDA records 2 decisions for Surgical Innovations Group Plc (Leeds West Yorkshire, GB) from 2007 to 2010: 2 510(k) clearances. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 3 predicates, 0 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 Surgical Innovations Group Plc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007: 12010: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Surgical Innovations Group Plc 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?

  • GCJLaparoscope, General & Plastic Surgery2decisions

Whose devices does it build on?

Its devices cite 3 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.

  • K070712Modification to: Yelloport Port Access SystemSurgical Innovations Group Plc · 20071cites it

What has FDA decided for it lately?

  • K100442Fastclamp Endoscopic Clamping SystemSurgical Innovations Group Plc · 2010
  • K070712Modification to: Yelloport Port Access SystemSurgical Innovations Group Plc · 20071 recall

All 2 as Surgical Innovations Group Plc →

What has been recalled?

1 recall linked to its devices; the latest:

  • K070712Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic…Jan 20, 2022Class II