510(k) Report

FDA applicant

Gi View, Ltd.

Ramat Gan, IL4 decisions2014–20260 recalls

FDA records 4 decisions for Gi View, Ltd. (Ramat Gan, IL) from 2014 to 2026: 4 510(k) clearances. All are in product code FDF (Colonoscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 147 days from receipt to decision, against 147 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Gi View, Ltd.”.

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 Gi View, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2014: 12016: 12023: 12026 (partial year): 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Gi View, Ltd. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Gi View, 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?

  • FDFColonoscope And Accessories, Flexible/Rigid4decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 147 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 147 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 20142cite it
  • K230588Aer-O-Scope Colonoscope SystemGi View, Ltd. · 20231cites it

What has FDA decided for it lately?

  • K261015Solo Scope Colonoscope SystemGi View, Ltd. · 2026
  • K230588Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2023
  • K161791Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2016
  • K141286Aer-O-Scope Colonoscope SystemGi View, Ltd. · 2014

All 3 as Gi View, Ltd. →The one decision as Gi View, Ltd. →