510(k) Report

FDA applicant

Louise C. Myers

Redmond, WA1 decision1999–19990 recalls

FDA records 1 decision for Louise C. Myers (Redmond, WA) in 1999: 1 510(k) clearance. All are in product code MSC (Barrier, Std, Oral Sex). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Louise C. Myers’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Louise C. Myers since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Louise C. Myers 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?

  • MSCBarrier, Std, Oral Sex1decision

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.

  • K990067Sheer Glyde DamsLouise C. Myers · 19991cites it

What has FDA decided for it lately?

  • K990067Sheer Glyde DamsLouise C. Myers · 1999

The one decision as Louise C. Myers →