Well Lead Medical Co., Ltd. - FDA 510(k) Cleared Devices

Cleared Mar 05, 2025

Wellead® Hydrophilic Intermittent Catheter Ready to Use

K241734 · GBM

Gastroenterology & Urology · 261d

Cleared May 22, 2023

PVC Hydrophilic Urethral Catheter

K220722 · EZD

Gastroenterology & Urology · 434d

Cleared Dec 16, 2022

Wellead Ureteral Catheter

K220036 · KOD

Gastroenterology & Urology · 345d

Cleared Jan 14, 2022

Wellead Endoscopic Seal

K211814 · ODC

Gastroenterology & Urology · 217d

Cleared Apr 08, 2021

Well Lead All Silicone Foley Catheter with Temperature Sensor

K202134 · EZL

Gastroenterology & Urology · 251d

Cleared Dec 09, 2020

ClearPetra Suction-Evacuation Sheath

K203119 · FED

Gastroenterology & Urology · 54d

Cleared Oct 11, 2017

Stomach Tube

K162340 · KNT

Gastroenterology & Urology · 415d

Cleared Oct 12, 2016

ClearPetra Suction-Evacuation Sheath

K161110 · FED

Gastroenterology & Urology · 175d

Cleared Jan 07, 2016

Well Lead Ureteral Access Sheath

K151084 · FED

Gastroenterology & Urology · 260d

Cleared Dec 15, 2014

WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER

K140667 · EZL

Gastroenterology & Urology · 272d

Cleared Oct 28, 2014

Well Lead PVC Urethral Catheter

K142563 · EZD

Gastroenterology & Urology · 47d

Cleared Feb 24, 2014

WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER

K133615 · EZD

Gastroenterology & Urology · 91d