| K260962 | Sphincterotome | Taewoong Medical Co., Ltd. | 2026-05-21 |
| 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... | 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 |
| K232476 | Disposable Sphincterotome | Zhejiang Soudon Medical Technology Co., Ltd. | 2023-11-07 |
| K230328 | Speedboat Flush SB1 Instrument | Creo Medical, Ltd. | 2023-10-31 |
| K233318 | AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enh... | Boston Scientific Corporation | 2023-10-27 |
| K233113 | ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) | Starmed Co., Ltd. | 2023-10-25 |
| K232162 | Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 3... | Boston Scientific Corporation | 2023-08-14 |
| K231533 | Habib EndoHPB | Boston Scientific Corporation | 2023-06-21 |
| K222421 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | 2023-05-03 |
| K223256 | Optimos™ Cystotome | Taewoong Medical Co., Ltd. | 2023-04-05 |
| K222542 | MCB UNIT Model: V10GMCBUS | Lamidey Noury Medical | 2022-09-21 |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | 2022-06-09 |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | 2022-03-21 |
| K213627 | RF Vapor System | Aqua Medical, Inc. | 2021-12-17 |
| K210934 | Sphincterotome / short-wire compatible, Sterile Sphincterotome | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-01 |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | 2021-05-27 |