Cleared Traditional

UROPUMP* FLUID MANAGEMENT SYSTEM

K894363 · Orthoconcept, Inc. · Gastroenterology & Urology
Aug 1989
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K894363 is an FDA 510(k) clearance for the UROPUMP* FLUID MANAGEMENT SYSTEM, a Resectoscope, Working Element (Class II — Special Controls, product code FDC), submitted by Orthoconcept, Inc. (Columbia, US). The FDA issued a Cleared decision on August 11, 1989, 28 days after receiving the submission on July 14, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K894363 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1989
Decision Date August 11, 1989
Days to Decision 28 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FDC — Resectoscope, Working Element
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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