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Disposable Endoscopy Valve Set

by Yangzhou Fartley Medical Instrument Technology Co., Ltd

510(k) K250732

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K250732↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK250732 Date20 Jun 2025ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 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  • Withdrawn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
ODC
FDA applicant
Yangzhou Fartley Medical Instrument Technology Co., Ltd.
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.

This device is classified as an Endoscope Channel Accessory and serves as a disposable valve system designed to fit onto endoscope working channels or ports. It regulates the flow of fluids, gases, and other materials during endoscopic procedures, ensuring unidirectional control to prevent contamination or backflow.

The set is supplied as a sterile, single-use product intended for use in gastroenterology and urology procedures. It is classified under FDA regulation 876.1500 and has received FDA 510(k) clearance and MDR authorization. Each valve unit is intended for one-time use and must be discarded after a single procedure to maintain sterility and prevent cross-contamination.

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Questions

AI-generated answers, 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.

  • What types of endoscopic procedures is this valve set designed to assist with, and why is it important to use it?

    This Disposable Endoscopy Valve Set is specifically designed for use in gastroenterology and urology procedures, where precise control of fluid and gas flow within the endoscope’s working channel is critical. It ensures unidirectional flow regulation, preventing contamination or backflow that could compromise sterility or patient safety during procedures like colonoscopies, cystoscopies, or ERCP. The single-use, sterile design also minimizes cross-contamination risks between patients.

  • Is this valve set reusable, or is it meant for one-time use only? What happens if it’s reused?

    The Disposable Endoscopy Valve Set is intended for single-use only and must be discarded after a single procedure. Reusing it violates sterility protocols and could introduce cross-contamination risks, compromising patient safety and potentially invalidating infection control measures. The manufacturer explicitly states it is designed for one-time use to maintain sterility and prevent procedural complications.

  • How is the valve set supplied, and what should I check before using it?

    The valve set is supplied as a sterile, single-use package ready for immediate use in endoscopic procedures. Before use, verify the sterility seal is intact and that the valve is compatible with your endoscope’s working channel diameter (though exact sizing isn’t specified, it’s designed for standard endoscopic ports). Ensure the package hasn’t been opened or exposed to contamination prior to procedure.

  • What regulatory approvals does this device hold, and how does that affect its use?

    The Disposable Endoscopy Valve Set holds FDA 510(k) clearance under regulation 876.1500 (Endoscope Channel Accessory) and MDR authorization, confirming it meets U.S. and EU safety standards for endoscopic use. This means it’s legally marketable in regulated regions for its intended purpose—regulating fluid/gas flow in endoscopy—but does not imply any specific clinical indication beyond what’s stated in the description.

  • Are there different sizes or models available for this valve set, or is it a one-size-fits-all design?

    The provided data does not specify multiple sizes or models for this valve set, implying it may be designed as a universal fit for standard endoscope working channels. However, compatibility depends on your specific endoscope’s port dimensions. Always confirm with the manufacturer or product documentation if your device requires a custom adapter or if alternative sizes exist for your use case.