Soma Access Systems LLC

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-0215-2015Class IIAxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 2March 24, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K113680SOMA ACCESS SYSTEMS EXACTTRACK PROCEDURE KITDecember 29, 2011