Cleared Traditional

ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY

K904158 · Welcon, Inc. · Gastroenterology & Urology
Nov 1990
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K904158 is an FDA 510(k) clearance for the ACCORDE(R) IRRIGATING SYRINGE/PROCEDURE TRAY, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by Welcon, Inc. (Providence, US). The FDA issued a Cleared decision on November 29, 1990, 83 days after receiving the submission on September 7, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K904158 FDA.gov
FDA Decision Cleared SEKD
Date Received September 07, 1990
Decision Date November 29, 1990
Days to Decision 83 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

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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