FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUNC IVF CENTERWELL AND ICSI DISHES
K Number: K090429
·
Decision Sep 18, 2009
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
1
Review Days
211
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
- NUNC IVF CENTERWELL AND ICSI DISHES
- K Number
- K090429
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermo Fisher Scientific (Nalge Nunc Intl)
- Date Received
- February 19, 2009
- Decision Date
- September 18, 2009
- 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