FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUNIVF DISHES
K Number: K080395
·
Decision Aug 13, 2008
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
24
Review Days
182
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
- SUNIVF DISHES
- K Number
- K080395
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- <Genx> Intl., Inc.
- Date Received
- February 13, 2008
- Decision Date
- August 13, 2008
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQK), ordered by most recent decision date.
SperSort Sperm Sorting Chip (IPG02)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
cryo-GO Vitrification Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
G-Vitri Vitrification Straw
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SpermAlign Sperm Separation Device
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by <Genx> Intl., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K112083 | LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES | May 3, 2012 | Substantially Equivalent |
| K053552 | GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA | May 19, 2006 | Substantially Equivalent |
| K053551 | MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL | May 9, 2006 | Substantially Equivalent |
| K040530 | MEDIA CULTURE SYSTEM | Jun 25, 2004 | Substantially Equivalent |
| K023033 | ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) | Nov 26, 2002 | Substantially Equivalent |
| K022590 | PVP (POLYVINYLPYRROLIDONE) | Aug 30, 2002 | Substantially Equivalent |
| K022352 | HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS) | Aug 28, 2002 | Substantially Equivalent |
| K022547 | ACIDIFIED TYRODES SOLUTION | Aug 28, 2002 | Substantially Equivalent |
| K022334 | HTF PLUS - HTF WITH NON-ESSENTIAL AMINO ACIDS | Aug 28, 2002 | Substantially Equivalent |
| K022330 | ALLGRAD 45 AND 90 CELL SEPARATION MEDIA | Aug 26, 2002 | Substantially Equivalent |