EndoClot

Laparoscope, General & Plastic Surgery

EndoClot Plus Co., Ltd.

The following data is part of a premarket notification filed by Endoclot Plus Co., Ltd. with the FDA for Endoclot.

Pre-market Notification Details

• Device ID: K162197
• 510k Number: K162197
• Device Name: EndoClot
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: EndoClot Plus Co., Ltd. 101 Room, B8 Building, 218 Xinghu Street Suzhou Industrial Park Suzhou, CN 215000
• Contact: Hendry Zhang
• Correspondent: Jonathan Hu; Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite NO.33 Room 303 Shanghai, CN 200093
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-08-05
• Decision Date: 2017-01-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
46972011720111	K162197	000