FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
VitriGuard
K Number: K180740
·
Decision May 4, 2018
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
14
Review Days
43
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Basic Information
- Device Name
- VitriGuard
- K Number
- K180740
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origio A/S
- Date Received
- March 22, 2018
- Decision Date
- May 4, 2018
- Product Code
- MQK
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQK | Labware, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Origio A/S
| K Number | Device Name | ||
|---|---|---|---|
| K200815 | VitriGuard | Jun 25, 2020 | Substantially Equivalent |
| K173624 | ORIGIO® Handling without phenol red (Cat. No. 8310), ORIGIO® Handling with phenol red (Cat. No. 8311) | Mar 2, 2018 | Substantially Equivalent |
| K172197 | SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS | Oct 13, 2017 | Substantially Equivalent |
| K161547 | Transem and EchoGen Embryo Transfer Catheters | Mar 9, 2017 | Substantially Equivalent |
| K162833 | VitriGuard | Feb 16, 2017 | Substantially Equivalent |
| K153267 | ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash | Jul 22, 2016 | Substantially Equivalent |
| K152932 | BlastGen | Feb 29, 2016 | Substantially Equivalent |
| K140317 | EMBRYOGEN | Jun 16, 2014 | Substantially Equivalent |
| K133912 | ORIGIO SEQUENTIAL FERT, ORIGIO SEQUENTIAL FERT WITH PHENOL RED, ORIGIO SEQUENTIAL CLEAV, ORIGIO SEQUENTIAL CLEAV, ORIGIO | May 14, 2014 | Substantially Equivalent |
| K133387 | ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED | Apr 29, 2014 | Substantially Equivalent |