Uterine Manipulator— 510(k) K172846

Substantially Equivalent

Beijing Hangtian Kadi Technology R&D Institute

FDA 510(k) clearance K172846 for Uterine Manipulator, Substantially Equivalent on 2018-06-26. Applicant: Beijing Hangtian Kadi Technology R&D Institute.

Clearance details

Applicant: Beijing Hangtian Kadi Technology R&D Institute
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2017-09-19
Decision date: 2018-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

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.