KARL STORZ 27086KC ULTRASONIC LITHOTRI— 510(k) K843101

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K843101 for KARL STORZ 27086KC ULTRASONIC LITHOTRI, Substantially Equivalent on 1984-12-11. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FEO
Advisory panel: Gastroenterology, Urology
Date received: 1984-08-07
Decision date: 1984-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FEO

product code FEO

Malfunction: 910
Other: 1
Total: 911

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.