K962393

Substantially Equivalent

KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: GCM
Advisory panel: Gastroenterology, Urology
Date received: 1996-06-20
Decision date: 1996-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Adverse events under product code GCM

product code GCM

Malfunction: 1,233
Total: 1,233

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.