Sclerotherapy Needle

Endoscopic Injection Needle, Gastroenterology-urology

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 Sclerotherapy Needle.

Pre-market Notification Details

• Device ID: K212668
• 510k Number: K212668
• Device Name: Sclerotherapy Needle
• Classification: Endoscopic Injection Needle, Gastroenterology-urology
• Applicant: Zhejiang Chuangxiang Medical Technology Co., LTD. Hangzhou, CN 311100
• Contact: Lucius Long
• Correspondent: Lucius Long; Zhejiang Chuangxiang Medical Technology Co., LTD. Building 50, No. 650 Hongfeng Road Donghu Street Yuhang District Hangzhou, CN 311100
• Product Code: FBK
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-08-23
• Decision Date: 2022-02-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06974173021411	K212668	000
06974173021244	K212668	000
06974173021237	K212668	000
06974173021220	K212668	000
06974173021213	K212668	000
06974173021206	K212668	000
06974173021190	K212668	000
06974173021183	K212668	000
06974173021176	K212668	000
06974173021169	K212668	000
06974173021152	K212668	000
06974173021145	K212668	000
06974173021138	K212668	000
06974173021121	K212668	000
06974173021114	K212668	000
06974173021251	K212668	000
06974173021268	K212668	000
06974173021404	K212668	000
06974173021398	K212668	000
06974173021381	K212668	000
06974173021374	K212668	000
06974173021367	K212668	000
06974173021350	K212668	000
06974173021343	K212668	000
06974173021336	K212668	000
06974173021329	K212668	000
06974173021312	K212668	000
06974173021305	K212668	000
06974173021299	K212668	000
06974173021282	K212668	000
06974173021275	K212668	000
06974173021107	K212668	000
06974173021091	K212668	000
06970401818006	K212668	000
06970401817993	K212668	000
06970401817986	K212668	000
06970401817979	K212668	000
06970401817962	K212668	000
06970401817955	K212668	000
06970401817948	K212668	000
06970401817931	K212668	000
06970401817924	K212668	000
06970401817917	K212668	000
06970401817900	K212668	000
50724995219210	K212668	000
10724995219205	K212668	000
10724995219199	K212668	000
06974173020933	K212668	000
06974173020940	K212668	000
06974173021084	K212668	000
06974173021077	K212668	000
06974173021060	K212668	000
06974173021053	K212668	000
06974173021046	K212668	000
06974173021039	K212668	000
06974173021022	K212668	000
06974173021015	K212668	000
06974173021008	K212668	000
06974173020995	K212668	000
06974173020988	K212668	000
06974173020971	K212668	000
06974173020964	K212668	000
06974173020957	K212668	000
10724995219182	K212668	000
06970401815739	K212668	000
06970401815791	K212668	000
06970401815784	K212668	000
06970401815777	K212668	000
06970401815760	K212668	000
06970401815753	K212668	000
06970401815746	K212668	000
06970401815722	K212668	000
06970401813995	K212668	000
06970401813971	K212668	000
06970401813964	K212668	000
06970401813940	K212668	000
06970401813933	K212668	000
06970401813919	K212668	000
06970401813902	K212668	000
06970401815807	K212668	000
06970401815814	K212668	000
06970401817894	K212668	000
06970401817887	K212668	000
06970401817870	K212668	000
06970401817863	K212668	000
06970401817856	K212668	000
06970401817849	K212668	000
06970401815890	K212668	000
06970401815883	K212668	000
06970401815876	K212668	000
06970401815869	K212668	000
06970401815852	K212668	000
06970401815845	K212668	000
06970401815838	K212668	000
06970401815821	K212668	000
06970401813896	K212668	000
06970401813889	K212668	000
06970401813506	K212668	000
06970401813216	K212668	000
06974173021541	K212668	000
06974173021534	K212668	000
06974173021527	K212668	000
06974173021510	K212668	000
06974173021503	K212668	000
06974173021497	K212668	000
06974173021480	K212668	000
06974173021473	K212668	000
06974173021466	K212668	000
06974173021459	K212668	000
06974173021442	K212668	000
06974173021435	K212668	000
06970401813513	K212668	000
06970401813537	K212668	000
06970401813865	K212668	000
06970401813858	K212668	000
06970401813841	K212668	000
06970401813834	K212668	000
06970401813759	K212668	000
06970401813742	K212668	000
06970401813735	K212668	000
06970401813728	K212668	000
06970401813605	K212668	000
06970401813582	K212668	000
06970401813575	K212668	000
06970401813568	K212668	000
06970401813551	K212668	000
06970401813544	K212668	000
06974173021428	K212668	000