ENDOFLATOR +— 510(k) K250388

Substantially Equivalent

Karl Storz SE & CO. KG

FDA 510(k) clearance K250388 for ENDOFLATOR +, Substantially Equivalent on 2025-09-22. Applicant: Karl Storz SE & CO. KG.

Clearance details

Applicant: Karl Storz SE & CO. KG
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2025-02-11
Decision date: 2025-09-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.