Plasma Surgical Inc.

FDA Regulatory Profile

Plasma Surgical Inc. appears in FDA public data with 1 recall, 3 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1794-2012, Class II) was initiated on April 27, 2012. Its most recent 510(k) clearance was granted on April 10, 2026.

Summary

Total Recalls
1
510(k) Clearances
3
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1794-2012Class IIPlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaApril 27, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K253917ARION ARC SystemApril 10, 2026
K080197PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMJune 24, 2008
K030819PLASMAJET SYSTEMAugust 5, 2004