KSEA N2O ENDOFLATOR— 510(k) K980134

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K980134 for KSEA N2O ENDOFLATOR, Substantially Equivalent on 1998-04-15. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 1998-01-15
Decision date: 1998-04-15
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.