UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450— 510(k) K010296

Substantially Equivalent

Marina Medical Instruments, Inc.

FDA 510(k) clearance K010296 for UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450, Substantially Equivalent on 2001-04-11. Applicant: Marina Medical Instruments, Inc..

Clearance details

Applicant: Marina Medical Instruments, Inc.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2001-01-31
Decision date: 2001-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hollywood, FL, US

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Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.