| 2026-06-04 | K253984 | Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | Gastroenterology-Urology |
| 2026-05-29 | K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | Gastroenterology-Urology |
| 2026-04-03 | K260724 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | Gastroenterology-Urology |
| 2026-03-12 | K250655 | Deep Capsule® (Deep Capsule US) | Digestaid - Artificial Intelligence Development SA | Gastroenterology-Urology |
| 2025-12-22 | K253664 | SKOUT system | Iterative Health | Gastroenterology-Urology |
| 2025-12-05 | K252504 | Gastric Alimetry | Alimetry , Ltd. | Gastroenterology-Urology |
| 2025-10-03 | K252178 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye, Ltd. | Gastroenterology-Urology |
| 2025-09-12 | K252586 | CADDIE | Odin Medical Limited | Gastroenterology-Urology |
| 2025-06-27 | K250984 | Maestro System (REF100) | Moon Surgical | Gastroenterology-Urology |
| 2025-06-24 | K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | Gastroenterology-Urology |
| 2025-05-09 | K251126 | SKOUT system | Iterative Health | Gastroenterology-Urology |
| 2025-01-24 | K244023 | MAGENTIQ-COLO (ME-APDS) | Magentiq Eye LTD | Gastroenterology-Urology |
| 2024-07-25 | 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 | Gastroenterology-Urology |
| 2024-07-24 | K240044 | CADDIE | Odin Medical Limited | Gastroenterology-Urology |
| 2024-07-03 | K241508 | SKOUT® system | Iterative Scopes, Inc. | Gastroenterology-Urology |
| 2024-04-19 | K240781 | SKOUT® system | Iterative Scopes, Inc. | Gastroenterology-Urology |
| 2024-01-12 | K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology |
| 2023-12-15 | K230751 | EW10-EC02 Endoscopy Support Program | FUJIFILM Corporation | Gastroenterology-Urology |
| 2023-12-12 | DEN230027 | NaviCam ProScan | Ankon Technologies co., ltd | Gastroenterology-Urology |
| 2023-07-25 | K223473 | ME-APDS™; MAGENTIQ-COLO™ | Magentiq Eye LTD | Gastroenterology-Urology |
| 2023-05-19 | K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology |
| 2023-04-07 | K230658 | SKOUT® system | Iterative Scopes Inc. | Gastroenterology-Urology |
| 2022-08-12 | K213686 | SKOUT Software | Iterative Scopes Inc. | Gastroenterology-Urology |
| 2021-11-19 | K211326 | EndoScreener | Chengdu Wision Medical Device Co., LTD. | Gastroenterology-Urology |
| 2021-07-23 | K211951 | GI Genius | Cosmo Artificial Intelligence - AI Ltd | Gastroenterology-Urology |
| 2021-04-09 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - AI, LTD | Gastroenterology-Urology |
| 2018-05-25 | K180163 | TransEnterix Senhance Surgical System | TransEnterix, Inc. | Gastroenterology-Urology |