Endomat Select, IBS Shaver Software, License— 510(k) K201355

Substantially Equivalent

Karl Storz SE & CO. KG

FDA 510(k) clearance K201355 for Endomat Select, IBS Shaver Software, License, Substantially Equivalent on 2020-07-22. Applicant: Karl Storz SE & CO. KG.

Clearance details

Applicant: Karl Storz SE & CO. KG
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2020-05-21
Decision date: 2020-07-22
Decision: Substantially Equivalent
Clearance type: Special
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.