510(k) K020951 ยท LKF Cannula, Manipulator/Injector, Uterine
H/S CATHETER SET (5F), MODEL 61-5005; H/S CATHETER SET (7F), MODEL 61-5007
| Applicant | Ackrad Laboratories, Cranford NJ, US |
| Decision | Substantially Equivalent, Apr 16, 2002 |
| Received | Mar 25, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020951
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2014 | CooperSurgical, Inc. CooperSurgical H/S CATHETER (PART # 61-5007)
Intended for Hysterosonography/ Hysterosalpingography. Terminated |
LKF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.