FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
<GENX> SPERM WASHING MEDIA
K Number: K991022
·
Decision Sep 9, 1999
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
24
Review Days
164
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Basic Information
- Device Name
- <GENX> SPERM WASHING MEDIA
- K Number
- K991022
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- <Genx> Intl., Inc.
- Date Received
- March 29, 1999
- Decision Date
- September 9, 1999
- 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
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CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
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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 <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 |
| K080395 | SUNIVF DISHES | Aug 13, 2008 | 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 |