FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
K Number: K983596
·
Decision Feb 5, 1999
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
25
Applicant Total
43
Review Days
115
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Basic Information
- Device Name
- INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
- K Number
- K983596
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6130
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Ob/Gyn
- Date Received
- October 13, 1998
- Decision Date
- February 5, 1999
- 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 Ob/Gyn
| K Number | Device Name | ||
|---|---|---|---|
| K062438 | BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500 | Oct 27, 2006 | Substantially Equivalent |
| K030441 | SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT | Aug 29, 2003 | Substantially Equivalent |
| K023850 | SYDNEY IVF EMBRYO BIOPSY MEDIUM | Jan 22, 2003 | Substantially Equivalent |
| K013597 | TAMPONADE UTERINE BALLOON CATHETER SET | Apr 17, 2002 | Substantially Equivalent |
| K002385 | COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM, | Sep 18, 2000 | Substantially Equivalent |
| K002383 | COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT | Sep 13, 2000 | Substantially Equivalent |
| K983595 | TRANSMYOMETRIAL EMBRYO TRANSFER SET | Feb 8, 1999 | Substantially Equivalent |
| K983642 | COOK MINI-INCUBATOR | Feb 1, 1999 | Substantially Equivalent |
| K983593 | OVUM PICK-UP ASPIRATION NEEDLES | Jan 21, 1999 | Substantially Equivalent |
| K983591 | INTRATUBAL TRANSFER SETS | Dec 21, 1998 | Substantially Equivalent |