Gi Supply

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1047-2016Class IILarge Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in hoJanuary 28, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K221042Renova RP Centesis PumpApril 19, 2023
K202376EverLift Submucosal Lifting AgentSeptember 30, 2020
K191923EverLift Submucosal Lifting AgentJune 20, 2020
K031360GI SUPPLY BILIARY STENTSeptember 24, 2003
K012411HP-ONESeptember 25, 2001
K970186GI SUPPLY PARACENTESIS PUMPFebruary 14, 1997
K970187RUNYON LARGE VOLUME PARACENTESIS KITFebruary 14, 1997
K944903HP-FASTApril 20, 1995
K931044OXY-BLOCOctober 4, 1993
K915816BITE BLOCK/MOUTHPIECE FOR ENDOSCOPYMarch 27, 1992