Medical Device Manufacturer · US , Pleasanton , CA

Calyxo, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2024

Recent clearances: CVAC® Aspiration System, CVAC Aspiration System, CVAC Image Processor

View 4 510(k) Devices ↓ Official Website

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Calyxo, Inc. Gastroenterology & Urology ✕

4 devices

1-4 of 4

Cleared Sep 15, 2026

CVAC® Aspiration System

Gastroenterology & Urology · 137d

Cleared Apr 13, 2026

CVAC Aspiration System

Gastroenterology & Urology · 21d

Cleared Mar 06, 2026

CVAC Image Processor

Gastroenterology & Urology · 60d

Cleared Feb 02, 2024

CVAC Aspiration System + CVAC Image Processor

Gastroenterology & Urology · 100d