Cleared Traditional

MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM

K895643 · Orthoconcept, Inc. · Gastroenterology & Urology
Oct 1989
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K895643 is an FDA 510(k) clearance for the MODIFIED 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 October 17, 1989, 50 days after receiving the submission on August 28, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K895643 FDA.gov
FDA Decision Cleared SESE
Date Received August 28, 1989
Decision Date October 17, 1989
Days to Decision 50 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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