K921883

Substantially Equivalent

ENDOSCOPE

Applicant: Optimed Technologies, Inc.
Product code: GCM
Advisory panel: Gastroenterology, Urology
Date received: 1992-04-21
Decision date: 1992-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, 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.