Endomat Select (UP220)— 510(k) K261706

Substantially Equivalent

KARL STORZ SE & CO. KG

FDA 510(k) clearance K261706 for Endomat Select (UP220), Substantially Equivalent on 2026-07-16. Applicant: KARL STORZ SE & CO. KG.

Clearance details

Applicant: KARL STORZ SE & CO. KG
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2026-05-22
Decision date: 2026-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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.