Zipline Medical

FDA Regulatory Profile

Summary

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

Recent Recalls

NumberClassProductDate
Z-1234-2015Class IIZip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated February 5, 2015
Z-1236-2015Class IIZip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated foFebruary 5, 2015
Z-1235-2015Class IIZip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, SteFebruary 5, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K170003Zip 4 Skin Closure DeviceAugust 18, 2017