| K252388 | francis medical | Vanquish Water Vapor Ablation Device | November 26, 2025 |
| K252889 | olympus medical systems corporation | Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) | November 25, 2025 |
| K250945 | olympus medical systems | Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Si | October 17, 2025 |
| K250351 | olympus medical systems corporation | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical | October 10, 2025 |
| K251104 | wilson-cook medical | SureTome SW Sphincterotome with DomeTip | September 29, 2025 |
| K251226 | aqua medical | Aqua Medical RF Vapor Ablation System | August 8, 2025 |
| K250584 | boston scientific corporation | Rezum System | June 11, 2025 |
| K242774 | creo medical | SpydrBlade Flex Instrument (PRD-RG1-001) | June 6, 2025 |
| K241855 | sb-kawasumi laboratories | SB Knife Jr2 (MD-47702 and MD-47702L) | March 26, 2025 |
| K242192 | beijing zksk technology co | Disposable Sphincterotome | February 6, 2025 |
| K243568 | wilson-cook medical | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord | January 17, 2025 |
| K241271 | aqua medical | Aqua Medical RF Vapor Ablation System | December 12, 2024 |
| K242061 | creo medical | Reusable Interface Cable 1.5 m (PRD-IFC-002) | August 15, 2024 |
| K232825 | jiangsu vedkang medical science and technology co | Disposable Sphincterotome | March 29, 2024 |
| K232633 | boston scientific | Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Elec | November 28, 2023 |
| K232476 | zhejiang soudon medical technology co | Disposable Sphincterotome | November 7, 2023 |
| K230328 | creo medical | Speedboat Flush SB1 Instrument | October 31, 2023 |
| K233318 | boston scientific corporation | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent a | October 27, 2023 |
| K233113 | starmed co | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7 | October 25, 2023 |
| K232162 | boston scientific corporation | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pr | August 14, 2023 |