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Endoscopic Water Pump

by Hangzhou AGS MedTech Co., Ltd.

510(k) K241704

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241704↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, 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 510(k) Substantially Equivalent · Traditional NumberK241704 Date20 Mar 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

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

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
OCX
Device class
Class II
Regulation
21 CFR Part 876.1500
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

The Endoscopic Water Pump is classified as an Endoscopic Irrigation/Suction System, designed to deliver controlled fluid irrigation during endoscopic procedures. It facilitates irrigation of the working channel in endoscopes or endotherapy devices, ensuring optimal visualization and cleaning during interventions such as colonoscopy, ERCP, or upper gastrointestinal endoscopy.

This device is intended for use in clinical settings, including hospitals and endoscopic units, and is supplied as a reusable medical instrument. It is not MRI-compatible and requires proper cleaning, sterilization, and maintenance between uses. Authorized under FDA 510K and MDR, the Endoscopic Water Pump adheres to regulatory standards for endoscopic irrigation systems, with a classification of Class II under FDA guidelines.

From the manufacturer

Hangzhou AGS MedTech Co., Ltd. -. Hangzhou AGS MedTech Co., Ltd. Endoscopic Water Pump Indication: Endoscopic Water Pump is intended to supply fluid to compatible endoscopes or endotherapy devices.

Source: bioags.com

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