Disposable Sclerotherapy Needle
K-Number: K190032 · 2020-02-27
ApplicantHangzhou AGS MedTech Co., Ltd.
Decision Date2020-02-27
Product CodeFBK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Disposable Sclerotherapy Needle is a medical device manufactured by Hangzhou AGS MedTech Co., Ltd.. It received FDA 510(k) clearance on 2020-02-27 under approval number K190032. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Disposable Sclerotherapy Needle?
Disposable Sclerotherapy Needle is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by Hangzhou AGS MedTech Co., Ltd.. The 510(k) number is K190032.
When was Disposable Sclerotherapy Needle approved by the FDA?
Disposable Sclerotherapy Needle received FDA 510(k) clearance on 2020-02-27, under approval number K190032.
What company makes Disposable Sclerotherapy Needle?
Disposable Sclerotherapy Needle is manufactured by Hangzhou AGS MedTech Co., Ltd..
What is the FDA product code for Disposable Sclerotherapy Needle?
The FDA product code for Disposable Sclerotherapy Needle is FBK.
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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.