510(k) Report

FDA applicant

Boddingtons Plastics, Ltd.

Tonbridge, GB5 decisions2012–20202 recalls

FDA records 5 decisions for Boddingtons Plastics, Ltd. (Tonbridge, GB) from 2012 to 2020: 5 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and FDA (Enteroscope And Accessories). Its devices cite 4 predicates, 2 of them its own earlier devices. 2 recalls are 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 Boddingtons Plastics, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2012: 12015: 12016: 12019: 12020: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2021

2020: 12021: 1
2012high 1 (2020) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Boddingtons Plastics, Ltd. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Boddingtons Plastics, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FEDEndoscopic Access Overtube, Gastroenterology-Urology4decisions
  • FDAEnteroscope And Accessories1decision

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K122565Arc EndocuffBoddingtons Plastics, Ltd. · 20123cite it
  • K151801Arc Endocuff VisionBoddingtons Plastics, Ltd. · 20152cite it

What has FDA decided for it lately?

  • K191330Arc EnterocuffBoddingtons Plastics, Ltd. · 2020
  • K191067Arc Endocuff Glide AEG110 & AEG120Boddingtons Plastics, Ltd. · 2019
  • K162205Arc EndoCuff and Arc EndoCuff VisionBoddingtons Plastics, Ltd. · 2016
  • K151801Arc Endocuff VisionBoddingtons Plastics, Ltd. · 20152 recalls
  • K122565Arc EndocuffBoddingtons Plastics, Ltd. · 2012

All 5 as Boddingtons Plastics, Ltd. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K151801Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0420501…Aug 3, 2021Class II
  • K151801Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device…Mar 11, 2020Class II