510(k) Report

FDA applicant

Xenolith Medical

Or Akiva, IL2 decisions2012–20130 recalls

FDA records 2 decisions for Xenolith Medical (Or Akiva, IL) from 2012 to 2013: 2 510(k) clearances. All are in product code OCY (Endoscopic Guidewire, Gastroenterology-Urology). Its devices cite 4 predicates, 0 of them its own earlier devices. No 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 Xenolith Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2012: 12013: 1
2012high 1 (2012) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

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

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Which product codes does it file in?

  • OCYEndoscopic Guidewire, Gastroenterology-Urology2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K123438Xenx Stone Management DeviceXenolith Medical · 2013
  • K113692XENXXenolith Medical · 2012

All 2 as Xenolith Medical →