510(k) Report

FDA applicant

Sca Molnlycke

Eddystone, PA1 decision1998–19980 recalls

FDA records 1 decision for Sca Molnlycke (Eddystone, PA) in 1998: 1 510(k) clearance. All are in product code MDA (Elastomer, Silicone, For Scar Management). 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Sca Molnlycke since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Sca Molnlycke 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?

  • MDAElastomer, Silicone, For Scar Management1decision

Who builds on its devices?

Later devices cite its devices 2 times; 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.

  • K974354Mepiform Adherent Silicone Dressing for Scar CareSca Molnlycke · 19982cite it

What has FDA decided for it lately?

  • K974354Mepiform Adherent Silicone Dressing for Scar CareSca Molnlycke · 1998

The one decision as Sca Molnlycke →