Medical Device Manufacturer · CN , Changzhou

Jiangsu Vedkang Medical Science and Technology Co., Ltd. - FDA 510(k)...

7 submissions · 7 cleared · Since 2022

Recent clearances: Disposable Sphincterotome, Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C), VedDilator ^TM (3-Stage Balloon Dilation Catheter)

7

Total

7

Cleared

0

Denied

FDA 510(k) Regulatory Record - Jiangsu Vedkang Medical Science and Technology Co., Ltd. Gastroenterology & Urology ✕

7 devices

1-7 of 7

Cleared Mar 29, 2024

Disposable Sphincterotome

Gastroenterology & Urology · 198d

Cleared Feb 26, 2024

Stone Extraction Balloon...

Gastroenterology & Urology · 171d

Cleared Feb 15, 2024

VedDilator ^TM (3-Stage Balloon Dilation Catheter)

Gastroenterology & Urology · 202d

Cleared Sep 12, 2023

Stone Extraction Baskets

Gastroenterology & Urology · 193d

Cleared Mar 28, 2023

Disposable Endoscopic Hemoclip

Gastroenterology & Urology · 251d

Cleared Sep 22, 2022

Disposable Polyp Snare

Gastroenterology & Urology · 254d

Cleared Jul 29, 2022

Injection Needle

Gastroenterology & Urology · 226d