Cleared Traditional

PEDIATRIC URINE COLLECTOR

K823411 · Sage Products, Inc. · Gastroenterology & Urology
Dec 1982
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K823411 is an FDA 510(k) clearance for the PEDIATRIC URINE COLLECTOR, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Sage Products, Inc. (Walker, US). The FDA issued a Cleared decision on December 28, 1982, 43 days after receiving the submission on November 15, 1982. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K823411 FDA.gov
FDA Decision Cleared SESE
Date Received November 15, 1982
Decision Date December 28, 1982
Days to Decision 43 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KNX — Collector, Urine, (and Accessories) For Indwelling Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5250

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