EUM 100Pro— 510(k) K150398

Substantially Equivalent

Ob Tools, Ltd.

FDA 510(k) clearance K150398 for EUM 100Pro, Substantially Equivalent on 2015-08-06. Applicant: Ob Tools, Ltd..

Clearance details

Applicant: Ob Tools, Ltd.
Product code: Code HGM
Advisory panel: Obstetrics/Gynecology
Date received: 2015-02-18
Decision date: 2015-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Migdal Ha-Emek, IL

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGM

product code HGM

Death: 35
Malfunction: 478
Total: 513

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.