KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE— 510(k) K940594

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K940594 for KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE, Substantially Equivalent on 1994-09-09. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FGA
Advisory panel: Gastroenterology, Urology
Date received: 1994-02-09
Decision date: 1994-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, D.C., DC, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FGA

product code FGA

Death: 7
Total: 7

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.