FDA 510(k)

Sphincterotome

K-Number: K260962 · 2026-05-21

Decision Date2026-05-21

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K260962. 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 Sphincterotome?

Sphincterotome is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Taewoong Medical Co., Ltd.. The 510(k) number is K260962.

When did Sphincterotome receive FDA 510(k) clearance?

Sphincterotome received FDA 510(k) clearance on 2026-05-21, under 510(k) number K260962.

Who is the listed applicant for Sphincterotome?

The FDA 510(k) record lists Taewoong Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sphincterotome?

The FDA product code for Sphincterotome is KNS.

Other records listing Taewoong Medical Co., Ltd. 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)

K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single 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 Corporation K251104SureTome™ SW Sphincterotome with DomeTipWilson-Cook Medical K251226Aqua 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.