510(k) Report

FDA applicant

F&S Medical Solutions, LLC

Omaha, NE1 decision2019–20190 recalls

FDA records 1 decision for F&S Medical Solutions, LLC (Omaha, NE) in 2019: 1 510(k) clearance. All are in product code GBM (Catheter, Urethral). Its devices cite 1 predicate, 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 F&S Medical Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2019: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — F&S Medical Solutions, LLC by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like F&S Medical Solutions, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GBMCatheter, Urethral1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K182511SimplCathF&S Medical Solutions, LLC · 2019

The one decision as F&S Medical Solutions, LLC →