510(k) Report

FDA applicant

Polichem S.A

Jackson, WI3 decisions2009–20150 recalls

FDA records 3 decisions for Polichem S.A (Jackson, WI) from 2009 to 2015: 3 510(k) clearances. Most are in product codes NUC (Lubricant, Personal) and KMF (Bandage, Liquid). Its devices cite 5 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Polichem S.A’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2009: 12012: 12015: 1
2009high 1 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Polichem S.A by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NUCLubricant, Personal2decisions
  • KMFBandage, Liquid1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K112217ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal MoisturizerPolichem S.A · 20122cite it
  • K143349GynomunalPolichem S.A · 20151cites it
  • K083087EcocelPolichem S.A · 20091cites it

What has FDA decided for it lately?

  • K143349GynomunalPolichem S.A · 2015
  • K112217ME Again (R) Long Lasting Vaginal Moisturizer, VH Essentials (R) Long Lasting Vaginal MoisturizerPolichem S.A · 2012
  • K083087EcocelPolichem S.A · 2009

All 3 as Polichem S.A →