Cleared Traditional

NEEDLELESS URINE SAMPLING PORT

K944236 · Kendall Healthcare Products Co. Div.Of Tyco Health · Gastroenterology & Urology
Nov 1994
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K944236 is an FDA 510(k) clearance for the NEEDLELESS URINE SAMPLING PORT, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on November 16, 1994, 76 days after receiving the submission on September 1, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K944236 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1994
Decision Date November 16, 1994
Days to Decision 76 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

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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