| 2026-05-21 |
K260962 |
Taewoong Medical Co., Ltd.
|
Sphincterotome |
| 2025-11-26 |
K252388 |
Francis Medical, Inc.
|
Vanquish Water Vapor Ablation Device |
| 2025-11-25 |
K252889 |
Olympus Medical Systems Corporation
|
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) |
| 2025-10-17 |
K250945 |
Olympus Medical Systems Corp.
|
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) |
| 2025-10-10 |
K250351 |
Olympus Medical Systems Corporation
|
Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) |
| 2025-09-29 |
K251104 |
Wilson-Cook Medical
|
SureTome SW Sphincterotome with DomeTip |
| 2025-08-08 |
K251226 |
Aqua Medical, Inc.
|
Aqua Medical RF Vapor Ablation System |
| 2025-06-11 |
K250584 |
Boston Scientific Corporation
|
Rezum System |
| 2025-06-06 |
K242774 |
Creo Medical, Ltd.
|
SpydrBlade Flex Instrument (PRD-RG1-001) |
| 2025-03-26 |
K241855 |
Sb-Kawasumi Laboratories, Inc.
|
SB Knife Jr2 (MD-47702 and MD-47702L) |
| 2025-02-06 |
K242192 |
Beijing Zksk Technology Co., Ltd.
|
Disposable Sphincterotome |
| 2025-01-17 |
K243568 |
Wilson-Cook Medical, Inc.
|
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord |
| 2024-12-12 |
K241271 |
Aqua Medical, Inc.
|
Aqua Medical RF Vapor Ablation System |
| 2024-08-15 |
K242061 |
Creo Medical, Ltd.
|
Reusable Interface Cable 1.5 m (PRD-IFC-002) |
| 2024-03-29 |
K232825 |
Jiangsu Vedkang Medical Science and Technology Co., Ltd.
|
Disposable Sphincterotome |
| 2023-11-28 |
K232633 |
Boston Scientific
|
Gold Probe Bipolar Electrohemostasis Catheter; Injection Gold Probe Bipolar Electrohemostasis Catheter |
| 2023-11-07 |
K232476 |
Zhejiang Soudon Medical Technology Co., Ltd.
|
Disposable Sphincterotome |
| 2023-10-31 |
K230328 |
Creo Medical, Ltd.
|
Speedboat Flush SB1 Instrument |
| 2023-10-27 |
K233318 |
Boston Scientific Corporation
|
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-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm) |
| 2023-10-25 |
K233113 |
Starmed Co., Ltd.
|
ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) |
| 2023-08-14 |
K232162 |
Boston Scientific Corporation
|
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 39 Sphincterotome |
| 2023-06-21 |
K231533 |
Boston Scientific Corporation
|
Habib EndoHPB |
| 2023-05-03 |
K222421 |
Hangzhou AGS MedTech Co., Ltd.
|
Sphincterotome |
| 2023-04-05 |
K223256 |
Taewoong Medical Co., Ltd.
|
Optimos Cystotome |
| 2022-09-21 |
K222542 |
Lamidey Noury Medical
|
MCB UNIT Model: V10GMCBUS |