Plasma Surgical Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
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
K080197PLASMAJET NEUTRAL PLASMA SURGERY SYSTEMJune 24, 2008
K030819PLASMAJET SYSTEMAugust 5, 2004