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FDA 510(k)

Sphincterotome

K-Number: K201121 · 2021-02-05

ApplicantHangzhou AGS MedTech Co., Ltd.
Decision Date2021-02-05
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Sphincterotome is a medical device manufactured by Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2021-02-05 under approval number K201121. 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 2021-02-05. It is manufactured by Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K201121.

When was Sphincterotome approved by the FDA?

Sphincterotome received FDA 510(k) clearance on 2021-02-05, under approval number K201121.

What company makes Sphincterotome?

Sphincterotome is manufactured by Hangzhou AGS MedTech Co., Ltd..

What is the FDA product code for Sphincterotome?

The FDA product code for Sphincterotome is KNS.

Other Devices by Hangzhou AGS MedTech Co., Ltd.

K172729Polypectomy Snare K172727Hemoclip K202237Locking device K201509Disposable Stone Extraction basket K192342Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) K200173Stone Retrieval Balloon

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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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