Cleared Traditional

K895643 - MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM

K895643 is an FDA 510(k) clearance for MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM, manufactured by Orthoconcept, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FDC cleared through the Traditional 510(k) pathway after a 50-day FDA review.

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

K895643 is an FDA 510(k) clearance for the MODIFIED UROPUMP* FLUID MANAGEMENT SYSTEM. Classified as Resectoscope, Working Element (product code FDC), Class II - Special Controls.

Submitted by Orthoconcept, Inc. (Columbia, US). The FDA issued a Cleared decision on October 17, 1989 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Orthoconcept, Inc. devices

FDA 510(k) Submission Details - K895643

510(k) Number K895643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 130d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FDC Device Classification - Class 2, Special Controls

Product Code FDC Resectoscope, Working Element
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FDC Resectoscope, Working Element

Devices cleared under the same product code (FDC) and FDA review panel - the closest regulatory comparables to K895643.
OLYMPUS WORKING ELEMENT FOR PROBES
K992141 · Olympus Winter & Ibe GmbH · Sep 1999
SHEATH, RESECTOSCOPE
K760182 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976
ELEMENT, WORKING
K760184 · V. Mueller O.V. Baxter Healthcare Corp. · Dec 1976
ADAPTER, RESECTOSCOPE
K760174 · V. Mueller O.V. Baxter Healthcare Corp. · Aug 1976