STORM-BASE 2.0— 510(k) K093603

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K093603 for STORM-BASE 2.0, Substantially Equivalent on 2010-03-18. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2009-11-20
Decision date: 2010-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

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.