Cleared Traditional

SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER

K860362 · Travenol Laboratories, S.A. · Gastroenterology & Urology
Apr 1986
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K860362 is an FDA 510(k) clearance for the SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on April 29, 1986, 89 days after receiving the submission on January 30, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K860362 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 1986
Decision Date April 29, 1986
Days to Decision 89 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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