GI Genius™ Module 100 - GI Genius™ Module 100 (GGM100.US)

No FDA recalls found in the data synced 25 Oct 2026.

510(k) Number

K233964 ↗

FDA Product Code

QNP

Models / Variants

GI Genius™ Module 100 (GGM100.US)

GI Genius™ Module 200 (GGM200.US)

ColonPRO™ 4.0 (CPRO40.US)

Device Class

Class II

Regulation

21 CFR Part 876.1520

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• GI Genius™ Module 300 (GGM300-US)

  Class II

  FDA 510(k) K261369 Active Cleared 29 May 2026

• GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)

  Class II

  FDA 510(k) K241887 Active Cleared 25 Jul 2024

• GI Genius

  Class II

  FDA 510(k) K211951 Active Cleared 23 Jul 2021

• GI Genius System 100 and GI Genius System 200

  Class II

  FDA 510(k) K231143 Active Cleared 19 May 2023

• GI Genius

  Class II

  FDA De Novo DEN200055 Active Cleared 9 Apr 2021 FDA 510(k)