510(k) Report

FDA applicant

Espiner Medical Limited

Glasgow, GB1 decision2011–20111 recall

FDA records 1 decision for Espiner Medical Limited (Glasgow, GB) in 2011: 1 510(k) clearance. All are in product code GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 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 Espiner Medical Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2011high 1 (2018) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Espiner Medical Limited by year, 2011–2026Sources: 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 Surgery1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K111845The Espiner Sac or E SacEspiner Medical Limited · 20115cite it

What has FDA decided for it lately?

  • K111845The Espiner Sac or E SacEspiner Medical Limited · 20111 recall

The one decision as Espiner Medical Limited →

What has been recalled?

1 recall linked to its devices; the latest:

  • K111845Espiner Tissue Retrieval System-Eco-Sac Trocar 12mm Vol: 1200 ml EMP160ECO-US-5…Jun 20, 2018Class II