Endoscopic Injection Needle

Endoscopic Injection Needle, Gastroenterology-urology

Beijing ZKSK Technology Co.,Ltd

The following data is part of a premarket notification filed by Beijing Zksk Technology Co.,ltd with the FDA for Endoscopic Injection Needle.

Pre-market Notification Details

• Device ID: K213239
• 510k Number: K213239
• Device Name: Endoscopic Injection Needle
• Classification: Endoscopic Injection Needle, Gastroenterology-urology
• Applicant: Beijing ZKSK Technology Co.,Ltd Building 9, 6 & No.6 Yuan Hengye North 7th Street, Yongle Economic Development Zone, Tongzho Beijing, CN 101105
• Contact: Ma Li
• Correspondent: Boyle Wang; Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, CN 200120
• Product Code: FBK
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-30
• Decision Date: 2022-06-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06934415067584	K213239	000
06934415067430	K213239	000
06934415067423	K213239	000
06934415067416	K213239	000
06934415067409	K213239	000
06934415067393	K213239	000
06934415067386	K213239	000
06934415067379	K213239	000
06934415067362	K213239	000
06934415067355	K213239	000
06934415067447	K213239	000
06934415067454	K213239	000
06934415067577	K213239	000
06934415067560	K213239	000
06934415067553	K213239	000
06934415067546	K213239	000
06934415067539	K213239	000
06934415067522	K213239	000
06934415067515	K213239	000
06934415067508	K213239	000
06934415067478	K213239	000
06934415067348	K213239	000
06934415067331	K213239	000
06934415067324	K213239	000
06934415067164	K213239	000
06934415067157	K213239	000
06934415067140	K213239	000
06934415067133	K213239	000
06934415067126	K213239	000
06934415067096	K213239	000
06934415067034	K213239	000
06934415067027	K213239	000
06934415067010	K213239	000
06934415067171	K213239	000
06934415067188	K213239	000
06934415067317	K213239	000
06934415067263	K213239	000
06934415067256	K213239	000
06934415067249	K213239	000
06934415067232	K213239	000
06934415067225	K213239	000
06934415067218	K213239	000
06934415067201	K213239	000
06934415067195	K213239	000
06934415067003	K213239	000
06934415066693	K213239	000
06934415067072	K213239	000
06934415067065	K213239	000
06934415067058	K213239	000
06934415067041	K213239	000
06934415067898	K213239	000
06934415067881	K213239	000
06934415067874	K213239	000
06934415067867	K213239	000
06934415067843	K213239	000
06934415066402	K213239	000
06934415066457	K213239	000
06934415066433	K213239	000
06934415066686	K213239	000
06934415066532	K213239	000
06934415066525	K213239	000
06934415066518	K213239	000
06934415066495	K213239	000
06934415066488	K213239	000
06934415066471	K213239	000
06934415066464	K213239	000
06934415067836	K213239	000
06934415067829	K213239	000
06934415067812	K213239	000
06934415067683	K213239	000
06934415067676	K213239	000
06934415067669	K213239	000
06934415067652	K213239	000
06934415067645	K213239	000
06934415067638	K213239	000
06934415067621	K213239	000
06934415067614	K213239	000
06934415067607	K213239	000
06934415067690	K213239	000
06934415067713	K213239	000
06934415067805	K213239	000
06934415067799	K213239	000
06934415067782	K213239	000
06934415067775	K213239	000
06934415067768	K213239	000
06934415067751	K213239	000
06934415067744	K213239	000
06934415067737	K213239	000
06934415067720	K213239	000
06934415067591	K213239	000