THE KARL STORZ HAMOU ENDOMAT— 510(k) K936231

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K936231 for THE KARL STORZ HAMOU ENDOMAT, Substantially Equivalent on 1995-01-24. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 1993-12-29
Decision date: 1995-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

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Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.