510(k) K013972 ยท LKF Cannula, Manipulator/Injector, Uterine
H/S ELLIPTOSPHERE CATHETER SET, MODEL 61-4005
| Applicant | Ackard Laboratories, Cranford NJ, US |
| Decision | Substantially Equivalent, Dec 17, 2001 |
| Received | Dec 3, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013972
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2023 | CooperSurgical, Inc. Cooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhe Open, Classified |
LKF | None listed |
| Dec 6, 2023 | CooperSurgical, Inc. CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet
Model: 61-4005S
For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology suc Open, Classified |
LKF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.