Cleared Traditional

K961442 - UNIVERSAL DRAINAGE TRAY
(FDA 510(k) Clearance)

K961442 · Customed, Inc. · Gastroenterology & Urology

May 1996

Decision

24d

Days

Class 2

Risk

K961442 is an FDA 510(k) clearance for the UNIVERSAL DRAINAGE TRAY. This device is classified as a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM).

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on May 9, 1996, 24 days after receiving the submission on April 15, 1996.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number	K961442 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 15, 1996
Decision Date	May 09, 1996
Days to Decision	24 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