FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED
K Number: K133387
·
Decision Apr 29, 2014
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
14
Review Days
175
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ORIGIO(R) SEQUENTIAL BLAST TM; ORIGIO(R) SEQUENTIAL BLAST TM WITH PHENOL RED
- K Number
- K133387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Origio A/S
- Date Received
- November 5, 2013
- Decision Date
- April 29, 2014
- Product Code
- MQL
- 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 |
|---|---|---|---|
| MQL | Media, Reproductive | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQL), ordered by most recent decision date.
Ultra-Fast Warm
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Fast Warm - NX
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Ultra-Fast Vitri; Ultra-Fast Warm
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Origio A/S
| K Number | Device Name | ||
|---|---|---|---|
| K200815 | VitriGuard | Jun 25, 2020 | Substantially Equivalent |
| K180740 | VitriGuard | May 4, 2018 | 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 |