CVAC Image Processor— 510(k) K260013

Substantially Equivalent

Calyxo, Inc.

FDA 510(k) clearance K260013 for CVAC Image Processor, Substantially Equivalent on 2026-03-06. Applicant: Calyxo, Inc..

Clearance details

Applicant: Calyxo, Inc.
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2026-01-05
Decision date: 2026-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

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Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.