Cleared Traditional

STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES

K913223 · Medical Device Inspection Co., Inc. · Gastroenterology & Urology
Sep 1991
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K913223 is an FDA 510(k) clearance for the STERILE DISPOSABLE URINE COLLECTOR & ACCESSORIES, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on September 4, 1991, 47 days after receiving the submission on July 19, 1991. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K913223 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 1991
Decision Date September 04, 1991
Days to Decision 47 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

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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