510(k) K932115 ยท LKF Cannula, Manipulator/Injector, Uterine
ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI
| Applicant | Blairden Precision Instruments, Inc., Lenexa KS, US |
| Decision | Substantially Equivalent, Jun 24, 1994 |
| Received | May 3, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 26, 2012 | Cooper Surgical, Inc. Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle
Ref: UMH700
The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning Terminated |
LKF | None listed |
| Nov 26, 2012 | Cooper Surgical, Inc. Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle
Ref: UMH750
The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where posi Terminated |
LKF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.