FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
K Number: K033903
·
Decision Jan 16, 2004
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
25
Applicant Total
104
Review Days
30
Basic Information
- Device Name
- MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES,
- K Number
- K033903
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.6130
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COOK UROLOGICAL, INC.
- Date Received
- December 17, 2003
- Decision Date
- January 16, 2004
- Product Code
- MQH
- 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 |
|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQH), ordered by most recent decision date.
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Flexipet Denuding Pipette, Flexipet Manipulation Pipette
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Other Clearances by COOK UROLOGICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K102141 | COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) | May 6, 2011 | Substantially Equivalent |
| K091767 | 3 WAY SILICONE FOLEY BALLOON CATHETER | Oct 9, 2009 | Substantially Equivalent |
| K082939 | COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400 | Sep 3, 2009 | Substantially Equivalent |
| K082066 | TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER | Nov 7, 2008 | Substantially Equivalent |
| K082536 | COOK WIRE GUIDES | Oct 27, 2008 | Substantially Equivalent |
| K082319 | INJEKT FILIFORM INJECTION NEEDLE | Sep 25, 2008 | Substantially Equivalent |
| K080525 | COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W | Apr 17, 2008 | Substantially Equivalent |
| K073496 | OPTILITE HOLMIUM LASER FIBERS | Jan 23, 2008 | Substantially Equivalent |
| K072521 | COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH | Nov 20, 2007 | Substantially Equivalent |
| K061371 | SYDNEY IVF SPERM CRYOPRESERVATION BUFFER | Aug 17, 2006 | Substantially Equivalent |