FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
K Number: K994417
·
Decision Mar 1, 2000
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
32
Applicant Total
104
Review Days
63
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Basic Information
- Device Name
- OVUM PICK-UP NEEDLES WITH AQ COATING, ASPIRATION NEEDLES WITH AQ COATING
- K Number
- K994417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6100
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Urological, Inc.
- Date Received
- December 29, 1999
- Decision Date
- March 1, 2000
- Product Code
- MQE
- 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 |
|---|---|---|---|
| MQE | Needle, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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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 |