510(k) Report

FDA applicant

Sle Limited

La Jolla, CA2 decisions1999–20020 recalls

FDA records 2 decisions for Sle Limited (La Jolla, CA) from 1999 to 2002: 2 510(k) clearances. All are in product code GWJ (Stimulator, Auditory, Evoked Response). Its devices cite 4 predicates, 1 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, neurology panel, where it files most

How often FDA has decided Sle Limited’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sle Limited since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sle Limited 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?

  • GWJStimulator, Auditory, Evoked Response2decisions

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K993177SABRESle Limited · 19992cite it

What has FDA decided for it lately?

All 2 as Sle Limited →