| K252388 | Vanquish Water Vapor Ablation Device | Francis Medical, Inc. | 2025-11-26 |
| K252889 | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | Olympus Medical Systems Corporation | 2025-11-25 |
| K250945 | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series) | Olympus Medical Systems Corp. | 2025-10-17 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) | Olympus Medical Systems Corporation | 2025-10-10 |
| K251104 | SureTome™ SW Sphincterotome with DomeTip | Wilson-Cook Medical | 2025-09-29 |
| K251226 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2025-08-08 |
| K250584 | Rezum System | Boston Scientific Corporation | 2025-06-11 |
| K242774 | SpydrBlade Flex Instrument (PRD-RG1-001) | Creo Medical, Ltd. | 2025-06-06 |
| K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | 2025-03-26 |
| K242192 | Disposable Sphincterotome | Beijing Zksk Technology Co., Ltd. | 2025-02-06 |
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | Wilson-Cook Medical, Inc. | 2025-01-17 |
| K241271 | Aqua Medical RF Vapor Ablation System | Aqua Medical, Inc. | 2024-12-12 |
| K242061 | Reusable Interface Cable 1.5 m (PRD-IFC-002) | Creo Medical, Ltd. | 2024-08-15 |
| K232825 | Disposable Sphincterotome | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-03-29 |
| K232633 | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter | Boston Scientific | 2023-11-28 |