DeviceClearance

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.. Device class: 2.

Summary

Calyxo's CVAC Aspiration System is filed under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 876.1500. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Special 510(k).

Calyxo filed from Pleasanton, California. The decision came 21 calendar days after FDA received it (March 23 to April 13, 2026).

Clearance details

Applicant
Calyxo, Inc.
Product code
Product code FED
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Pleasanton, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code FED

product code FED
Death
10
Total
10

Source: openFDA MAUDE database, through . 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.