Cleared Special

K222279 - Rusch Intermittent Urethral Catheters (FDA 510(k) Clearance)

K222279 · Teleflex Medical · Gastroenterology & Urology

Aug 2022

Decision

31d

Days

Class 2

Risk

K222279 is an FDA 510(k) clearance for the Rusch Intermittent Urethral Catheters, a Catheter, Coude (Class II — Special Controls, product code EZC), submitted by Teleflex Medical (Morrisville, US). The FDA issued a Cleared decision on August 29, 2022, 31 days after receiving the submission on July 29, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K222279 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2022
Decision Date	August 29, 2022
Days to Decision	31 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF