Cleared Traditional

BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR

K851470 · Lic-Orthion · Gastroenterology & Urology
Jun 1985
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K851470 is an FDA 510(k) clearance for the BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR, a Collector, Urine, (and Accessories) For Indwelling Catheter (Class II — Special Controls, product code KNX), submitted by Lic-Orthion (Washington, US). The FDA issued a Cleared decision on June 12, 1985, 58 days after receiving the submission on April 15, 1985. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5250.

Submission Details

510(k) Number K851470 FDA.gov
FDA Decision Cleared SESE
Date Received April 15, 1985
Decision Date June 12, 1985
Days to Decision 58 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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