Cleared Special

Actreen Hi-Lite Intermittent Urinary Catheters

K192577 · B.Braun Medical, Inc. · Gastroenterology & Urology
May 2020
Decision
231d
Days
Class 2
Risk

About This 510(k) Submission

K192577 is an FDA 510(k) clearance for the Actreen Hi-Lite Intermittent Urinary Catheters, a Catheter, Urethral (Class II — Special Controls, product code GBM), submitted by B.Braun Medical, Inc. (Allentown, US). The FDA issued a Cleared decision on May 7, 2020, 231 days after receiving the submission on September 19, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K192577 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 2019
Decision Date May 07, 2020
Days to Decision 231 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code GBM — Catheter, Urethral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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