510(k) K983596 ยท MQH Microtools, Assisted Reproduction (Pipettes)
INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
| Applicant | Cook Ob/Gyn, Spencer IN, US |
| Decision | Substantially Equivalent, Feb 5, 1999 |
| Received | Oct 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983596
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | Cook Vascular Inc. Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | None listed |
| Sep 18, 2008 | Cook Vascular Inc. Flexipet Manipulation pipette 300 micron. The device is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | None listed |
| Sep 16, 2008 | Cook Vascular Inc. Flexipet Manipulation Pipette 300 micron. The product is boxed with 1 vial of 10 pipettes. This product is used for the intracytoplasmic single sperm injection of oocytes. Terminated |
MQH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.