KARL STORZ FRIMBERGER VARIOGUIDE— 510(k) K962212

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K962212 for KARL STORZ FRIMBERGER VARIOGUIDE, Substantially Equivalent on 1996-12-13. Applicant: KARL STORZ Endoscopy-America, Inc..

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code FDT
Advisory panel: Gastroenterology, Urology
Date received: 1996-06-10
Decision date: 1996-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDT

product code FDT

Death: 86
Injury: 1,954
Malfunction: 14,912
Total: 16,952

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.