INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
FDA 510(k) clearance K983596 · decided 1999-02-05
Clearance details
- K-number
- K983596
- Device name
- INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
- Applicant
- Cook Ob/Gyn
- Decision
- Substantially Equivalent
- Date received
- 1998-10-13
- Decision date
- 1999-02-05
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- MQH
- Device class
- 2
- Regulation number
- 884.6130
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device recall (Z-2176-2008) | Cook Vascular Inc. | 2008-09-18 |
| Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic sing recall (Z-2177-2008) | Cook Vascular Inc. | 2008-09-18 |
| Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. recall (Z-2178-2008) | Cook Vascular Inc. | 2008-09-16 |