Atlas FDA

Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord

FDA 510(k) clearance K243568 · decided 2025-01-17

Clearance details

K-number
K243568
Device name
Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord
Applicant
Wilson-Cook Medical, Inc.
Decision
Substantially Equivalent
Date received
2024-11-18
Decision date
2025-01-17
Days to decision
60 days
Clearance type
Special
Product code
KNS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Winston-Salem, NC, US
Third-party review
No
Expedited review
No

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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
Aqua Medical RF Vapor Ablation System (K241271)Aqua Medical, Inc.2024-12-12

Recalls involving this device

RecordFirmDate
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 0 recall (Z-1362-2026)Wilson-Cook Medical Inc.2026-02-13