Cleared Traditional

Teleflex Rusch SoftSimplastic Foley Catheters

K212077 · Teleflexmedical, Inc. · Gastroenterology & Urology
Jul 2023
Decision
755d
Days
Class 2
Risk

About This 510(k) Submission

K212077 is an FDA 510(k) clearance for the Teleflex Rusch SoftSimplastic Foley Catheters, a Catheter, Retention Type, Balloon (Class II — Special Controls, product code EZL), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on July 27, 2023, 755 days after receiving the submission on July 2, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K212077 FDA.gov
FDA Decision Cleared SESE
Date Received July 02, 2021
Decision Date July 27, 2023
Days to Decision 755 days
Submission Type Traditional
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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