Cleared Traditional

URI-SURE

K852619 · Ashai Co. , Ltd. · Gastroenterology & Urology
Aug 1985
Decision
68d
Days
Class 2
Risk

About This 510(k) Submission

K852619 is an FDA 510(k) clearance for the URI-SURE, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Ashai Co. , Ltd. (Australia, AU). The FDA issued a Cleared decision on August 27, 1985, 68 days after receiving the submission on June 20, 1985. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K852619 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1985
Decision Date August 27, 1985
Days to Decision 68 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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