Disposable Sphincterotome
K-Number: K242192 · 2025-02-06
ApplicantBeijing Zksk Technology Co., Ltd.
Decision Date2025-02-06
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Disposable Sphincterotome is a medical device manufactured by Beijing Zksk Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-06 under approval number K242192. 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 2025-02-06. It is manufactured by Beijing Zksk Technology Co., Ltd.. The 510(k) number is K242192.
When was Disposable Sphincterotome approved by the FDA?
Disposable Sphincterotome received FDA 510(k) clearance on 2025-02-06, under approval number K242192.
What company makes Disposable Sphincterotome?
Disposable Sphincterotome is manufactured by Beijing Zksk Technology Co., Ltd..
What is the FDA product code for Disposable Sphincterotome?
The FDA product code for Disposable Sphincterotome is KNS.
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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.