Cosmo Artificial Intelligence - Ai, Ltd.
Cosmo Artificial Intelligence - Ai, Ltd. has 0 FDA recalls, 0 inspections, 6 510(k) clearances and 0 compliance actions on record.
- Latest 510(k)
- May 29, 2026
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 6 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | May 29, 2026 |
| K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI… | Jul 25, 2024 |
| K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Jan 12, 2024 |
| K231143 | GI Genius System 100 and GI Genius System 200 | May 19, 2023 |
| K211951 | GI Genius | Jul 23, 2021 |
| DEN200055 | GI Genius | Apr 9, 2021 |