Atlas FDA

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

FDA 510(k) clearance K232162 · decided 2023-08-14

Clearance details

K-number
K232162
Device name
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
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2023-07-21
Decision date
2023-08-14
Days to decision
24 days
Clearance type
Special
Product code
KNS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Boston Scientific Corporation

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Sphincterotome (K260962)Taewoong Medical Co., Ltd.2026-05-21
Vanquish Water Vapor Ablation Device (K252388)Francis Medical, Inc.2025-11-26
Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) (K252889)Olympus Medical Systems Corporation2025-11-25
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) (K250945)Olympus Medical Systems Corp.2025-10-17
Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U) (K250351)Olympus Medical Systems Corporation2025-10-10
SureTome™ SW Sphincterotome with DomeTip (K251104)Wilson-Cook Medical2025-09-29
Aqua Medical RF Vapor Ablation System (K251226)Aqua Medical, Inc.2025-08-08
Rezum System (K250584)Boston Scientific Corporation2025-06-11
SpydrBlade Flex Instrument (PRD-RG1-001) (K242774)Creo Medical, Ltd.2025-06-06
SB Knife Jr2 (MD-47702 and MD-47702L) (K241855)Sb-Kawasumi Laboratories, Inc.2025-03-26
Disposable Sphincterotome (K242192)Beijing Zksk Technology Co., Ltd.2025-02-06
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord (K243568)Wilson-Cook Medical, Inc.2025-01-17

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Axonics Sacral Neuromodulation System (P180046/S113)Boston Scientific Corporation2026-08-07
Axonics Sacral Neuromodulation System (P190006/S113)Boston Scientific Corporation2026-08-07
Innova™ Self Expanding Stent System (P140028/S087)Boston Scientific Corporation2026-08-06
Ranger™ Paclitaxel-Coated Balloon Catheter (P190019/S043)Boston Scientific Corporation2026-08-04
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S009)Boston Scientific Corporation2026-07-30
Axonics Sacral Neuromodulation System (P180046/S110)Boston Scientific Corporation2026-07-24
Axonics Sacral Neuromodulation System (P190006/S110)Boston Scientific Corporation2026-07-24
S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219) (P110042/S215)Boston Scientific Corporation2026-07-23