KARL STORZ 3D VIDEO SYSTEM— 510(k) K001362

Name: FDA 510(k) clearance K001362
Creator: U.S. Food and Drug Administration
Published: 2000-07-17

Substantially Equivalent

Karl Storz Imaging, Inc.

FDA 510(k) clearance K001362 for KARL STORZ 3D VIDEO SYSTEM, Substantially Equivalent on 2000-07-17. Applicant: Karl Storz Imaging, Inc.. Device class: 2.

Clearance details

Applicant: Karl Storz Imaging, Inc.
Product code: Code GCI
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-28
Decision date: 2000-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Karl Storz Imaging, Inc.

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K003325 — KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM2001-04-27
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K990154 — KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM1999-06-01
K974391 — KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM1998-01-30
K973252 — KARL STORZ DIRECT COUPLED CAMERA HEAD1997-11-24

Adverse events under product code GCI

product code GCI

Malfunction: 635
Total: 635

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.