510(k) Report

FDA applicant

Cerkamed Wojciech Pawlowski

Stalowa Wola, Podkarpacie, PL1 decision2013–20130 recalls

FDA records 1 decision for Cerkamed Wojciech Pawlowski (Stalowa Wola, Podkarpacie, PL) in 2013: 1 510(k) clearance. All are in product code KJJ (Cleanser, Root Canal). Its devices cite 2 predicates, 0 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

How often FDA has decided Cerkamed Wojciech Pawlowski’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Cerkamed Wojciech Pawlowski by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KJJCleanser, Root Canal1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K130180Cleanser Root CanalCerkamed Wojciech Pawlowski · 2013

The one decision as Cerkamed Wojciech Pawlowski →