Hemoclip

Hemostatic Metal Clip For The Gi Tract

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 Hemoclip.

Pre-market Notification Details

• Device ID: K172727
• 510k Number: K172727
• Device Name: Hemoclip
• Classification: Hemostatic Metal Clip For The Gi Tract
• Applicant: Hangzhou AGS MedTech CO., Ltd Building 6, Kangxin Road No.597 Qianjiang Economic Development Area Hangzhou, CN 311106
• Contact: Chunqi Han
• Correspondent: Ethan Liu; Shanghai Thinkwell Consulting Co., Ltd. Xinling Rd, 211/6F Shanghai, CN 201100
• Product Code: PKL
• CFR Regulation Number: 876.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-09-11
• Decision Date: 2018-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50724995220681	K172727	000
16959664946944	K172727	000
10724995219151	K172727	000
10724995219168	K172727	000
10724995219175	K172727	000
10724995190511	K172727	000
10724995190528	K172727	000
10724995215795	K172727	000
10724995215801	K172727	000
10849771039195	K172727	000
10849771039225	K172727	000
66959664909012	K172727	000
16959664922580	K172727	000
16959664915148	K172727	000
10724995220690	K172727	000
16959664900137	K172727	000
16959664900144	K172727	000
16959664900151	K172727	000
16959664900168	K172727	000
16959664900434	K172727	000
16959664902698	K172727	000
16959664902995	K172727	000
16959664903978	K172727	000
16959664910891	K172727	000
16959664914066	K172727	000
66959664909562	K172727	000
66959664911251	K172727	000
26959664900929	K172727	000
66959664902686	K172727	000
66959664902983	K172727	000
26959664903005	K172727	000
26959664903104	K172727	000
26959664903135	K172727	000
26959664904194	K172727	000
26959664911024	K172727	000
26959664911215	K172727	000
66959664911220	K172727	000
66959664911244	K172727	000
66959664910902	K172727	000
66959664910841	K172727	000
66959664911268	K172727	000
66959664900392	K172727	000
66959664900422	K172727	000
66959664900446	K172727	000
66959664903300	K172727	000
66959664903331	K172727	000
66959664910872	K172727	000
66959664910926	K172727	000
66959664910940	K172727	000
66959664911183	K172727	000
66959664910797	K172727	000
66959664911749	K172727	000