Disposable Sclerotherapy Needle

Endoscopic Injection Needle, Gastroenterology-urology

Hangzhou AGS MedTech CO., Ltd

The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd with the FDA for Disposable Sclerotherapy Needle.

Pre-market Notification Details

• Device ID: K190032
• 510k Number: K190032
• Device Name: Disposable Sclerotherapy Needle
• Classification: Endoscopic Injection Needle, Gastroenterology-urology
• Applicant: Hangzhou AGS MedTech CO., Ltd Building 5, Building 6, Kangxin Road No.597 Yuhang District Hangzhou, CN 310000
• Contact: Xiangyong Yu
• Correspondent: Yangping Fu; Hangzhou AGS MedTech CO., Ltd Building 5, Building 6, Kangxin Road No.597 Yuhang District Hangzhou, CN 310000
• Product Code: FBK
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-07
• Decision Date: 2020-02-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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