Cleared Traditional

AMSURE URETHRAL CATHETERIZATION TRAY

K030712 · Amsino International, Inc. · Gastroenterology & Urology
May 2003
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K030712 is an FDA 510(k) clearance for the AMSURE URETHRAL CATHETERIZATION TRAY, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by Amsino International, Inc. (Ontario, US). The FDA issued a Cleared decision on May 23, 2003, 78 days after receiving the submission on March 6, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K030712 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2003
Decision Date May 23, 2003
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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