CVAC Aspiration System— 510(k) K260965

Substantially Equivalent

Calyxo, Inc.

FDA 510(k) clearance K260965 for CVAC Aspiration System, Substantially Equivalent on 2026-04-13. Applicant: Calyxo, Inc..

Clearance details

Applicant: Calyxo, Inc.
Product code: Code FED
Advisory panel: Gastroenterology, Urology
Date received: 2026-03-23
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.