Calyxo, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1396-2025Class ICVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examinatioFebruary 19, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K260013CVAC Image ProcessorMarch 6, 2026
K233472CVAC Aspiration System + CVAC Image ProcessorFebruary 2, 2024