510(k) K970492 ยท LKF Cannula, Manipulator/Injector, Uterine
INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER
| Applicant | Ackrad Laboratories, Cranford NJ, US |
| Decision | Substantially Equivalent, Apr 9, 1997 |
| Received | Feb 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970492
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 11, 2014 | CooperSurgical, Inc. Cooper Surgical TAMPA CATHETER 5 French 33 cm.
Intended for Hysterosonography.
Model Number: 61-2005 Terminated |
LKF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.