KARL STORZ OR1 SCB CONTROL (WU300)— 510(k) K232406

Name: FDA 510(k) clearance K232406
Creator: U.S. Food and Drug Administration
Published: 2023-10-03

Substantially Equivalent

Karl Storz SE & CO. KG

FDA 510(k) clearance K232406 for KARL STORZ OR1 SCB CONTROL (WU300), Substantially Equivalent on 2023-10-03. Applicant: Karl Storz SE & CO. KG. Device class: 2.

Clearance details

Applicant: Karl Storz SE & CO. KG
Product code: Code ODA
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-08-10
Decision date: 2023-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuttlingen, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.