Disposable Sphincterotome
K-Number: K232476 · 2023-11-07
Decision Date2023-11-07
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Disposable Sphincterotome is a medical device manufactured by Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-07 under approval number K232476. 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 Disposable Sphincterotome?
Disposable Sphincterotome is a medical device that received FDA 510(k) clearance on 2023-11-07. It is manufactured by Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K232476.
When was Disposable Sphincterotome approved by the FDA?
Disposable Sphincterotome received FDA 510(k) clearance on 2023-11-07, under approval number K232476.
What company makes Disposable Sphincterotome?
Disposable Sphincterotome is manufactured by Zhejiang Soudon Medical Technology Co., Ltd..
What is the FDA product code for Disposable Sphincterotome?
The FDA product code for Disposable Sphincterotome is KNS.
Other Devices by Zhejiang Soudon Medical Technology Co., Ltd.
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.