ORIGIO, Inc
FDA Regulatory Profile
ORIGIO, Inc appears in FDA public data with 1 recall, 15 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1946-2014, Class II) was initiated on June 20, 2014. Its most recent 510(k) clearance was granted on June 25, 2020.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 15
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1946-2014 | Class II | Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-9 | June 20, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K200815 | VitriGuard | June 25, 2020 |
| K180740 | VitriGuard | May 4, 2018 |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 83 | March 2, 2018 |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | October 13, 2017 |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | March 9, 2017 |
| K162833 | VitriGuard | February 16, 2017 |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | July 22, 2016 |
| K152932 | BlastGen | February 29, 2016 |
| K140317 | EMBRYOGEN | June 16, 2014 |
| K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQU | May 14, 2014 |
| K132870 | Origio Gas Line Filter | May 7, 2014 |
| K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED | April 29, 2014 |
| K133707 | SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS | April 16, 2014 |
| K120136 | EMBRYOGEN | September 26, 2012 |
| K100367 | MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229 | August 27, 2010 |