510(k) Report

FDA applicant

Morwel Corp.

Mchenry, IL4 decisions1983–19960 recalls

FDA records 4 decisions for Morwel Corp. (Mchenry, IL) from 1983 to 1996: 4 510(k) clearances. Most are in product codes JCX (Apparatus, Suction, Ward Use, Portable…) and LFL (Instrument, Ultrasonic Surgical). 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 Morwel Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Morwel Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Morwel Corp. 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?

  • JCXApparatus, Suction, Ward Use, Portable, Ac-Powered1decision
  • LFLInstrument, Ultrasonic Surgical1decision

Who builds on its devices?

Later devices cite its devices 3 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.

  • K962525Ultra-Safe Ultrasonic Aspirator SystemMorwel Corp. · 19963cite it

What has FDA decided for it lately?

  • K962525Ultra-Safe Ultrasonic Aspirator SystemMorwel Corp. · 1996
  • K841160Morwel AspiratorMorwel Corp. · 1984
  • K841159Suction TipsMorwel Corp. · 1984
  • K831520Morwel CannulaMorwel Corp. · 1983

All 4 as Morwel Corp. →