Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Plasma Surgical with 4 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Apr 10, 2026: ARION ARC System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Apr 10, 2026 | ARION ARC SystemK253917 · GEI | 510(k) clearances |
| Nov 20, 2012 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMK121977 · GEI | 510(k) clearances |
| Apr 27, 2012 | PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system is a neutral plasma surgery sClass II · Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a v | Device recalls |
| Jun 24, 2008 | PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMK080197 · GEI | 510(k) clearances |
| Aug 5, 2004 | PLASMAJET SYSTEMK030819 · GEI | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
