ENDOFLATOR 40, ENDOFLATOR 50— 510(k) K161554

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K161554 for ENDOFLATOR 40, ENDOFLATOR 50, Substantially Equivalent on 2017-03-02. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2016-06-06
Decision date: 2017-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

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.