Single Use Hemoclip

Hemostatic Metal Clip For The Gi Tract

Zhejiang Chuangxiang Medical Technology Co., LTD.

The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Single Use Hemoclip.

Pre-market Notification Details

• Device ID: K212669
• 510k Number: K212669
• Device Name: Single Use Hemoclip
• Classification: Hemostatic Metal Clip For The Gi Tract
• Applicant: Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road, Yuhang District Hangzhou, CN 311100
• Contact: Lucius Long
• Correspondent: Lucius Long; Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road, Yuhang District Hangzhou, CN 311100
• Product Code: PKL
• CFR Regulation Number: 876.4400 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-23
• Decision Date: 2022-05-27

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
16970401815385	K212669	000
16970401815354	K212669	000
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