510(k) Report

FDA applicant

Enzysurge, Ltd.

Rosh Ha'Ayin, IL3 decisions2006–20200 recalls

FDA records 3 decisions for Enzysurge, Ltd. (Rosh Ha'Ayin, IL) from 2006 to 2020: 3 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and NAD (Dressing, Wound, Occlusive). Its devices cite 7 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2020

2009: 12020: 1
2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Enzysurge, Ltd.’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?

  • FRODressing, Wound, Drug2decisions
  • NADDressing, Wound, Occlusive1decision

Whose devices does it build on?

Its devices cite 7 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.

  • K093227Silverstream and DermaseptEnzysurge, Ltd. · 20091cites it
  • K060046DermastreamEnzysurge, Ltd. · 20061cites it

What has FDA decided for it lately?

  • K200767SilverStream GelEnzysurge, Ltd. · 2020
  • K093227Silverstream and DermaseptEnzysurge, Ltd. · 2009
  • K060046DermastreamEnzysurge, Ltd. · 2006

All 3 as Enzysurge, Ltd. →