FDA Product Code
FDA Product Code QNP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1520
510(k) Clearances — 23 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260133 | CADDIE | Odin Medical Limited | 2026-09-12 | Special | PDF ↗ |
| K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2026-08-07 | Special | PDF ↗ |
| K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | 2026-08-05 | Traditional | PDF ↗ |
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026-05-29 | Special | PDF ↗ |
| K260724 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2026-04-03 | Special | PDF ↗ |
| K253664 | SKOUT system | Iterative Health | 2025-12-22 | Special | PDF ↗ |
| K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-10-03 | Special | PDF ↗ |
| K252586 | CADDIE | Odin Medical Limited | 2025-09-12 | Special | PDF ↗ |
| K251126 | SKOUT system | Iterative Health | 2025-05-09 | Special | PDF ↗ |
| K244023 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | 2025-01-24 | Special | PDF ↗ |
| K241887 | 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) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-07-25 | Special | PDF ↗ |
| K240044 | CADDIE | Odin Medical Limited | 2024-07-24 | Traditional | PDF ↗ |
| K241508 | SKOUT® system | Iterative Scopes, Inc. | 2024-07-03 | Special | PDF ↗ |
| K240781 | SKOUT® system | Iterative Scopes, Inc. | 2024-04-19 | Special | PDF ↗ |
| K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2024-01-12 | Special | PDF ↗ |
| K230751 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2023-12-15 | Traditional | PDF ↗ |
| K223473 | ME-APDS; MAGENTIQ-COLO | Magentiq Eye, Ltd. | 2023-07-25 | Traditional | PDF ↗ |
| K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023-05-19 | Special | PDF ↗ |
| K230658 | SKOUT® system | Iterative Scopes, Inc. | 2023-04-07 | Special | PDF ↗ |
| K213686 | SKOUT Software | Iterative Scopes, Inc. | 2022-08-12 | Traditional | PDF ↗ |
| K211326 | EndoScreener | Chengdu Wision Medical Device Co., Ltd. | 2021-11-19 | Traditional | PDF ↗ |
| K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021-07-23 | Special | PDF ↗ |
| DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021-04-09 | Direct | — |
Product code QNP · Class II · Gastroenterology, Urology. Data: openFDA.