MAJOLI UTERINE MANIPULATOR/INJECTOR— 510(k) K911887

Substantially Equivalent

Cook Ob/Gyn

FDA 510(k) clearance K911887 for MAJOLI UTERINE MANIPULATOR/INJECTOR, Substantially Equivalent on 1991-07-26. Applicant: Cook Ob/Gyn.

Clearance details

Applicant: Cook Ob/Gyn
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 1991-04-29
Decision date: 1991-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spencer, IN, 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.