510(k) K961752 ยท LKF Cannula, Manipulator/Injector, Uterine
H/S CATHETER SET(61-3005, 61-3007, 61-3605, 61-3607)
| Applicant | Ackrad Laboratories, Cranford NJ, US |
| Decision | Substantially Equivalent, Aug 8, 1996 |
| Received | May 6, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961752
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2023 | CooperSurgical, Inc. Cooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesio Open, Classified |
LKF | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Mckesson GYNECATH H/S CATHETER 5FR (10/CS)
Model Number: 11-19610 Open, Classified |
LKF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.