510(k) Report

FDA applicant

Endochoice, Inc.

Alpharetta, GA27 decisions2010–20161 recall

FDA records 27 decisions for Endochoice, Inc. (Alpharetta, GA) from 2010 to 2016: 27 510(k) clearances. Most are in product codes FEQ (Pump, Air, Non-Manual, For Endoscope) and OCX (Endoscopic Irrigation/Suction System). Its devices cite 35 predicates, 14 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 Endochoice, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

6in 2016

2010: 32011: 12012: 22013: 52014: 72015: 32016: 6
2010high 7 (2014) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2010high 1 (2015) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — Endochoice, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Endochoice, Inc.’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?

  • FEQPump, Air, Non-Manual, For Endoscope6decisions
  • OCXEndoscopic Irrigation/Suction System4decisions
  • FGEStents, Drains And Dilators For The Biliary Ducts2decisions
  • FDFColonoscope And Accessories, Flexible/Rigid2decisions
  • FDISnare, Flexible2decisions
  • FBKEndoscopic Injection Needle, Gastroenterology-Urology2decisions

Also: FDS (2), PEA (1), OCZ (1), ODC (1), ESW (1), KGE (1).

Whose devices does it build on?

Its devices cite 35 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 14 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.

  • K111821Biopsy ValveEndochoice, Inc. · 20114cite it
  • K093003Bonastent BiliaryEndochoice, Inc. · 20102cite it
  • K161167Seal Single-Use Biopsy ValveEndochoice, Inc. · 20162cite it
  • K132065Injection NeedleEndochoice, Inc. · 20142cite it
  • K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc. · 20161cites it
  • K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare, Models Befg and BefrEndochoice, Inc. · 20101cites it

What has FDA decided for it lately?

  • K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc. · 2016
  • K161482EndoChoice Water Bottle Cap Irrigation SystemEndochoice, Inc. · 2016
  • K161167Seal Single-Use Biopsy ValveEndochoice, Inc. · 2016
  • K160403SmartStart Air/Water and Suction ValvesEndochoice, Inc. · 2016
  • K153588EndoChoice Water Bottle Cap SystemEndochoice, Inc. · 2016
  • K151475EndoChoice Select Injection NeedleEndochoice, Inc. · 2016
  • K152182Fuse Gastroscopy SystemEndochoice, Inc. · 2015
  • K152580rescuenetEndochoice, Inc. · 2015

All 27 as Endochoice, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K141598Fuse 1C ColonoscopeDec 18, 2015Class II