ManipulatOR PRO, ManipulatOR— 510(k) K150519

Substantially Equivalent

Gynetech Pty. , Ltd.

FDA 510(k) clearance K150519 for ManipulatOR PRO, ManipulatOR, Substantially Equivalent on 2015-08-19. Applicant: Gynetech Pty. , Ltd..

Clearance details

Applicant: Gynetech Pty. , Ltd.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2015-03-02
Decision date: 2015-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richmond, AU

Download summary PDF View on FDA.gov ↗

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.