510(k) K250584
- Device
- Rezum System
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K250584
- Product code
- KNS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-11
- Date received
- 2025-02-27
- Regulation
- 876.4300
- Classification name
- Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Joseph Tabor
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers
- 3002808148
- 1057358
- 1825146
- 2183446
- 3010288205
- 3015895045
- 9680515
- 3006621103
- 3014769442
- 2650143
- 3008720584
- 2183744
- 1222168
- 3012536737
- 3007593903
- 3014925413
- 3006546082
- 3001845648
- 9612074
- 3003724334
- 1651252
- 3008132398
- 3011050570
- 3013557562
- 9610612
- 3007960282
- 3010202439
- 2246552
- 3014620201
- 9616684
- 1225687
- 1721676
- 1000163068
- 1820334
- 3033589330
- 3006950086
- 3005099803
- 8010877
- 3002807314
- 3013557681
- 2916714
- 3015975397
- 1223925
- 1828132
- 3030733800
- 3007305485
- 3004904811
- 1037905
- 3004083736
- 3009183442
- 1056129
- 1649518
- 3031233199
- 3009217531
- 3021171301
- 3008040402
- 3002807310
- 3009526575
- 2936485
- 3014579161
- 3007695959
- 2431166
- 1000393132
- 3014342096
- 1724474
- 1319639
- 3010188783
- 1061927
- 9611102
- 3004784537
- 9614641
- 3008386005
- 3030446844
- 3013440400
- 3012494290
- 3024021261
- 3005580113
- 3004215117
- 3014615697
- 3010273872
- 3002806337
- 9610617
- 8010047
- 3010707607
- 9610773
- 3023102955
- 9681260
- 1222140
- 3004111573
- 2124215
- 9617070
- 8010456
- 3035434483
- 9680718
- 1321175
- 1220592
- 3003790304
- 3013247477
- 3004837686
- 2133936
- 3003902943
- 2020550
- 9611283
- 3006696607
- 3002894438
- 9710641
- 1000121056
- 3015309643
- 1721504
- 1219602
- 2183613
- 3013526170
- 3018094310
- 1528319
- 3025311469
- 1320894
- 9611503
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code KNS
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |