SureTome SW Sphincterotome with DomeTip
K-Number: K251104 · 2025-09-29
ApplicantWilson-Cook Medical
Decision Date2025-09-29
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
SureTome SW Sphincterotome with DomeTip is a medical device manufactured by Wilson-Cook Medical. It received FDA 510(k) clearance on 2025-09-29 under approval number K251104. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SureTome SW Sphincterotome with DomeTip?
SureTome SW Sphincterotome with DomeTip is a medical device that received FDA 510(k) clearance on 2025-09-29. It is manufactured by Wilson-Cook Medical. The 510(k) number is K251104.
When was SureTome SW Sphincterotome with DomeTip approved by the FDA?
SureTome SW Sphincterotome with DomeTip received FDA 510(k) clearance on 2025-09-29, under approval number K251104.
What company makes SureTome SW Sphincterotome with DomeTip?
SureTome SW Sphincterotome with DomeTip is manufactured by Wilson-Cook Medical.
What is the FDA product code for SureTome SW Sphincterotome with DomeTip?
The FDA product code for SureTome SW Sphincterotome with DomeTip is KNS.
Related Devices (Code: KNS)
K152771SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - LongSumitomo Bakelite Co., Ltd.
K160417Rezum SystemNxthera, Inc.
K160241Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215Olympus Medical Systems Corp.
K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp.
K171993Zimmon Needle Knife PapillotomeWilson-Cook Medical Inc./Cook Endoscopy
K171983Creo Medical Electrosurgical System including Speedboat RS2 Surgical AccessoryCreo Medical, Ltd.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.