CALCULASE II— 510(k) K140964

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K140964 for CALCULASE II, Substantially Equivalent on 2014-09-04. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2014-04-15
Decision date: 2014-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: El Segundo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.