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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical. It received FDA 510(k) clearance on 2025-09-29 under 510(k) 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. The listed applicant is Wilson-Cook Medical. The 510(k) number is K251104.

When did SureTome™ SW Sphincterotome with DomeTip receive FDA 510(k) clearance?

SureTome™ SW Sphincterotome with DomeTip received FDA 510(k) clearance on 2025-09-29, under 510(k) number K251104.

Who is the listed applicant for SureTome™ SW Sphincterotome with DomeTip?

The FDA 510(k) record lists Wilson-Cook Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SureTome™ SW Sphincterotome with DomeTip?

The FDA product code for SureTome™ SW Sphincterotome with DomeTip is KNS.

Other records listing Wilson-Cook Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KNS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single 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.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems CorporationK251226Aqua Medical RF Vapor Ablation SystemAqua Medical, Inc.

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.

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