FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
K Number: K994361
·
Decision Feb 18, 2000
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
49
Applicant Total
17
Review Days
53
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
- ESP FOUR WELL TISSUE CULTURE PLATE, ESP SIX WELL TISSUE CULTURE PLATE, ESP MICRO SIX WELL TISSUE CULTURE PLATE, ESP WELL
- K Number
- K994361
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genesis Industries, Inc.
- Date Received
- December 27, 1999
- Decision Date
- February 18, 2000
- 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 Genesis Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962828 | EVERT-IT | Feb 10, 1997 | Substantially Equivalent |
| K880377 | NOVO VIVO MODEL #17140 AND #17135 | Apr 4, 1988 | Substantially Equivalent |
| K880376 | NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP | Feb 16, 1988 | Substantially Equivalent |
| K833287 | SATIN CAST ECONOCAST | Jan 3, 1984 | Substantially Equivalent |
| K833290 | C & B 40 PENTRO C & B40 | Jan 3, 1984 | Substantially Equivalent |
| K833278 | C & B 45 | Dec 29, 1983 | Substantially Equivalent |
| K833289 | C & B 61 PENTRON C & B61 | Dec 29, 1983 | Substantially Equivalent |
| K833280 | SUPRA AP CHOICE 83 | Dec 26, 1983 | Substantially Equivalent |
| K833285 | RX IV PENTRON IV | Dec 22, 1983 | Substantially Equivalent |
| K833288 | C & B57 PENTRON C & B57 | Dec 20, 1983 | Substantially Equivalent |