Cleared Special

Well Lead All Silicone Foley Catheter with Temperature Sensor

K202134 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology
Apr 2021
Decision
251d
Days
Class 2
Risk

About This 510(k) Submission

K202134 is an FDA 510(k) clearance for the Well Lead All Silicone Foley Catheter with Temperature Sensor, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 8, 2021, 251 days after receiving the submission on July 31, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K202134 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2020
Decision Date April 08, 2021
Days to Decision 251 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZL — Catheter, Retention Type, Balloon
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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