FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
READYSWIM
K Number: K011346
·
Decision Jun 28, 2001
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
258
Applicant Total
12
Review Days
57
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Basic Information
- Device Name
- READYSWIM
- K Number
- K011346
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6180
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidacon International AB
- Date Received
- May 2, 2001
- Decision Date
- June 28, 2001
- 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
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CaseBio Culture w/HSA (CMH5); CaseBio Handling w/HSA (WHH5)
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Fast Warm - NX
FDA 510(k)
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Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])
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FDA Class 2
·Obstetrics/Gynecology
Ultra-Fast Vitri; Ultra-Fast Warm
FDA 510(k)
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·Obstetrics/Gynecology
FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicin
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Nidacon International AB
| K Number | Device Name | ||
|---|---|---|---|
| K131145 | PROINSERT | Feb 20, 2014 | Substantially Equivalent |
| K092107 | VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010 | Jun 15, 2010 | Substantially Equivalent |
| K023206 | SPERM CRYOPROTEC | Nov 8, 2002 | Substantially Equivalent |
| K022443 | SPERMASSIST | Aug 28, 2002 | Substantially Equivalent |
| K011607 | SPERMCATCH | Aug 10, 2001 | Substantially Equivalent |
| K012123 | NIDOIL | Aug 3, 2001 | Substantially Equivalent |
| K011606 | PURESPERM BUFFER | Jul 12, 2001 | Substantially Equivalent |
| K002630 | PURESPERM WASH | Nov 21, 2000 | Substantially Equivalent |
| K002623 | PURESPERM 40 AND PURESPERM 80 | Nov 20, 2000 | Substantially Equivalent |
| K984172 | MODIFICATION OF PURESPERM | Jan 14, 1999 | Substantially Equivalent |