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Modified Uropump Fluid Management System

by Orthoconcept, Inc.

510(k) K895643

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK895643 Date17 Oct 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FDC
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Modified Uropump Fluid Management System is a fluid management device designed for use in urological procedures. It is classified as a resectoscope working element and is intended for managing irrigation and fluid evacuation during endoscopic surgeries, particularly in urology and gastroenterology settings.

This device is supplied as a reusable system and is intended for use in controlled clinical environments. It is regulated under FDA 510(k) clearance (K895643) and falls under the classification of Class II medical devices (regulation number 876.1500). The system is not described as MRI-safe or single-use in the provided data, and no specific sterility requirements beyond standard medical device reprocessing protocols are mentioned.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Modified Uropump Fluid Management System used for?

    The Modified Uropump Fluid Management System is designed specifically for managing irrigation and fluid evacuation during endoscopic surgeries, particularly in urology and gastroenterology. It serves as a resectoscope working element, ensuring controlled fluid dynamics to maintain visibility and efficiency during procedures like transurethral resections.

  • Is the Modified Uropump Fluid Management System single-use or reusable?

    The Modified Uropump Fluid Management System is supplied as a reusable device. It is intended for use in controlled clinical environments where proper reprocessing protocols can be followed to maintain safety and sterility between procedures.

  • What regulatory approval does the Modified Uropump Fluid Management System hold?

    The device holds FDA 510(k) clearance under the reference number K895643, classified as a Class II medical device under regulation number 876.1500. This clearance indicates it is deemed substantially equivalent to a legally marketed predicate device and is authorized for use in the United States.

  • What specialties is the Modified Uropump Fluid Management System intended for?

    The system is primarily intended for use in urology and gastroenterology specialties. Its design supports fluid management during endoscopic procedures commonly performed in these fields, ensuring optimal conditions for surgical precision.

  • Are there any specific sterility requirements mentioned for the Modified Uropump Fluid Management System?

    The provided data does not specify unique sterility requirements beyond standard medical device reprocessing protocols. As a reusable device, it must adhere to established clinical reprocessing guidelines to ensure safety and sterility between uses.