KSEA CO2 ENDOFLATOR— 510(k) K963423

Substantially Equivalent

Karl Storz Endoscopy

FDA 510(k) clearance K963423 for KSEA CO2 ENDOFLATOR, Substantially Equivalent on 1997-05-27. Applicant: Karl Storz Endoscopy.

Clearance details

Applicant: Karl Storz Endoscopy
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1996-08-30
Decision date: 1997-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.