ORIGIO, Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1946-2014Class IIName: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-9June 20, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K200815VitriGuardJune 25, 2020
K180740VitriGuardMay 4, 2018
K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 83March 2, 2018
K172197SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPSOctober 13, 2017
K161547Transem and EchoGen Embryo Transfer CathetersMarch 9, 2017
K162833VitriGuardFebruary 16, 2017
K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm WashJuly 22, 2016
K152932BlastGenFebruary 29, 2016
K140317EMBRYOGENJune 16, 2014
K133912ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUMay 14, 2014
K132870Origio Gas Line FilterMay 7, 2014
K133387ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL REDApril 29, 2014
K133707SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTSApril 16, 2014
K120136EMBRYOGENSeptember 26, 2012
K100367MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229August 27, 2010