DEBP— 510(k) K092783

Substantially Equivalent

Enko , Ltd.

FDA 510(k) clearance K092783 for DEBP, Substantially Equivalent on 2009-10-22. Applicant: Enko , Ltd..

Clearance details

Applicant: Enko , Ltd.
Product code: Code HGX
Advisory panel: Obstetrics/Gynecology
Date received: 2009-09-10
Decision date: 2009-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cigli - Izmir, TR

Download summary PDF View on FDA.gov ↗

Adverse events under product code HGX

product code HGX

Injury: 758
Other: 2
Total: 760

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.