Wellead Endoscopic Seal

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Trade Name

Wellead Endoscopic Seal EUDAMED

Wellead GUDID

Generic Name

Endoscope working-channel valve, single-use

Model / Reference

U04D010110, Endoscopic Seal, Type II, O05A010310, O05A010330, O05A010320

FDA applicant

Well Lead Medical Co., Ltd.

Primary DI / UDI-DI

06944932785113, 06925816602306, 06925816602320, 06925816602313

Basic UDI-DI

69449327FU04D01M8, 69449327FU04D02MA

510(k) Number

K211814 ↗

FDA Product Code

ODC

EMDN Code

U090399 Single-use instruments for urogenital endoscopy - other

GMDN Term

Endoscope working-channel valve, single-use

Device Class

Class I EUDAMED

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.1500

EU market of registration

Germany

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from Well Lead Medical Co., Ltd →

• What is the primary purpose of the Wellead Endoscopic Seal during endoscopic procedures?

  The Wellead Endoscopic Seal is designed to create a secure, watertight barrier within the working channel of an endoscope. Its main purpose is to prevent fluid leakage—such as irrigation fluids, bodily fluids, or air—during procedures like gastroscopy or cystoscopy. This ensures a clear visual field for the clinician and maintains procedural integrity by isolating the internal lumen from external contamination or pressure changes.

• Is the Wellead Endoscopic Seal reusable, or is it intended for single-use only?

  The Wellead Endoscopic Seal is explicitly labeled as a single-use device. While it is non-sterile at the time of manufacture, it must be sterilized by the user prior to its first use. However, after use, it should not be reused, as this could compromise its integrity and pose risks to patient safety.

• Which endoscope models is the Wellead Endoscopic Seal compatible with?

  The Wellead Endoscopic Seal is compatible with a wide range of endoscope models, as indicated by its FDA registration numbers (e.g., 3011193403, 1825146, etc.). These numbers correspond to specific endoscope working channel diameters and types commonly used in gastroenterology and urology. Always verify compatibility with your endoscope’s specifications before use.

• How should the Wellead Endoscopic Seal be stored before use?

  Since the device is non-sterile, it must be sterilized by the user prior to first use following standard medical device sterilization protocols (e.g., autoclave, ethylene oxide, or gamma irradiation). Storage should adhere to manufacturer guidelines for non-sterile medical devices—typically in a clean, dry environment, protected from moisture and extreme temperatures, until sterilization is performed.

• What regulatory pathways has the Wellead Endoscopic Seal undergone, and what does that mean for its use?

  The Wellead Endoscopic Seal has received FDA 510(k) clearance and EU MDR authorization, confirming compliance with regulatory standards for endoscopic accessories. The FDA classification (Class II, under regulation 876.1500) and the Substantially Equivalent (SE) determination indicate it meets performance criteria for endoscopic channel accessories in gastroenterology and urology. This does not imply an indication but confirms its regulatory standing for use in approved procedures.