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FDA 510(k)

Disposable Sphincterotome

K-Number: K232825 · 2024-03-29

ApplicantJiangsu Vedkang Medical Science and Technology Co., Ltd.
Decision Date2024-03-29
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Disposable Sphincterotome is a medical device manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-29 under approval number K232825. 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 2024-03-29. It is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd.. The 510(k) number is K232825.

When was Disposable Sphincterotome approved by the FDA?

Disposable Sphincterotome received FDA 510(k) clearance on 2024-03-29, under approval number K232825.

What company makes Disposable Sphincterotome?

Disposable Sphincterotome is manufactured by Jiangsu Vedkang Medical Science and Technology Co., Ltd..

What is the FDA product code for Disposable Sphincterotome?

The FDA product code for Disposable Sphincterotome is KNS.

Other Devices by Jiangsu Vedkang Medical Science and Technology Co., Ltd.

K220089Disposable Polyp Snare K213914Injection Needle K230598Stone Extraction Baskets K222146Disposable Endoscopic Hemoclip K232752Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) K232245VedDilator ^TM (3-Stage Balloon Dilation Catheter)

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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.

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