K991303

Substantially Equivalent

VISTA ORPC WITH INFOMATIX INTRAOP SOFTWARE

Applicant: Vista Medical Technologies, Inc.
Product code: GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1999-04-16
Decision date: 1999-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westborough, MA, US

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.