510(k) Report

FDA applicant

Surgical Innovations Plc

Leeds, GB12 decisions1991–20214 recalls

FDA records 12 decisions for Surgical Innovations Plc (Leeds, GB) from 1991 to 2021: 12 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 10 predicates, 2 of them its own earlier devices. 4 recalls are linked to its devices.

FDA’s records also spell it “Surgical Innovations Corp.”, “Surgical Innovations Limited”.

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 Plc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2010: 12012: 22013: 12019: 12021: 1
2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

2in 2023

2022: 22023: 2
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Surgical Innovations 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 Surgery7decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • HIFInsufflator, Laparoscopic1decision
  • OCWEndoscopic Tissue Approximation Device1decision
  • GAGStapler, Surgical1decision

Whose devices does it build on?

Its devices cite 10 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 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.

  • K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 20062cite it
  • K962193Portland TrocarsSurgical Innovations Plc · 19961cites it
  • K190592YelloPort Elite Port Access SystemSurgical Innovations Limited · 20191cites it
  • K100109Logiflex Laparoscopic Band Positioning DeviceSurgical Innovations Plc · 20101cites it
  • K123110Pretzelflex Surgical Retractor Model SHR7301Surgical Innovations Plc · 20131cites it

What has FDA decided for it lately?

  • K210495Port Access SystemSurgical Innovations Limited · 20212 recalls
  • K190592YelloPort Elite Port Access SystemSurgical Innovations Limited · 20192 recalls
  • K123110Pretzelflex Surgical Retractor Model SHR7301Surgical Innovations Plc · 2013
  • K112659Surgical RetractorsSurgical Innovations Plc · 2012
  • K111986Logic Laparoscopic Instrument SystemSurgical Innovations Plc · 2012
  • K100109Logiflex Laparoscopic Band Positioning DeviceSurgical Innovations Plc · 2010
  • K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
  • K955393Numo NM-1000 Automatic Carbon-Dioxide for EndoscopeSurgical Innovations Plc · 1997

All 7 as Surgical Innovations Plc →All 3 as Surgical Innovations Corp. →All 2 as Surgical Innovations Limited →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K210495YelloPort Elite, REF: EO0507005, 5x70 Optical Trocar, , Rx Only, SterileRMar 28, 2023Class II
  • K210495YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileRMar 28, 2023Class II
  • K190592YelloPort Elite Universal Seal. For use in laparoscopic procedures.Jun 2, 2022Class II
  • K190592Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite…Jan 20, 2022Class II