VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100— 510(k) K021290

Substantially Equivalent

Vista Medical Technologies, Inc.

FDA 510(k) clearance K021290 for VISTA VISUALIZATION SYSTEM, MODEL 9000, VISTA VISUALIZATION SYSTEM WITH VOICE ACTIVATION AND PIP, MODEL 9100, Substantially Equivalent on 2002-06-28. Applicant: Vista Medical Technologies, Inc..

Clearance details

Applicant: Vista Medical Technologies, Inc.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2002-04-23
Decision date: 2002-06-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Westborough, MA, US

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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.