Cleared Traditional

PVC Hydrophilic Urethral Catheter

K220722 · Well Lead Medical Co., Ltd. · Gastroenterology & Urology
May 2023
Decision
434d
Days
Class 2
Risk

About This 510(k) Submission

K220722 is an FDA 510(k) clearance for the PVC Hydrophilic Urethral Catheter, a Catheter, Straight (Class II — Special Controls, product code EZD), submitted by Well Lead Medical Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 22, 2023, 434 days after receiving the submission on March 14, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K220722 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2022
Decision Date May 22, 2023
Days to Decision 434 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code EZD — Catheter, Straight
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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