510(k) Report

FDA applicant

Ksea

Culver City, CA1 decision2006–20060 recalls

FDA records 1 decision for Ksea (Culver City, CA) in 2006: 1 510(k) clearance. All are in product code FAS (Electrode, Electrosurgical, Active, Urological). 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 Ksea’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ksea since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ksea by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FASElectrode, Electrosurgical, Active, Urological1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K061541Ksea Bipolar ElectrotomeKsea · 20061cites it

What has FDA decided for it lately?

  • K061541Ksea Bipolar ElectrotomeKsea · 2006

The one decision as Ksea →