AMSure 100% Silicone Foley Catheter

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.

Generic Name

Indwelling urethral drainage balloon catheter, non-antimicrobial

Model / Ref / Catalog

AS41020S, 1

Primary DI / UDI-DI

10704411001959

Basic UDI-DI

B-10704411001959

510(k) Number

K051059 ↗ 510(k)

K082815 ↗ GUDID

FDA Product Code

EZL

EMDN Code

U020201 Ureteral catheters for occlusion

GMDN Term

Indwelling urethral drainage balloon catheter, non-antimicrobial

Device Class

Class IIa EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 876.5130

EU market of registration

Netherlands

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

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See all devices from Amsino International, Inc. →

• What materials is the AMSURE 100% Silicone Foley Catheter made from and why does that matter for patient comfort?

  The AMSURE Foley Catheter is constructed entirely from 100% silicone, which provides chemical and thermal stability, low surface tension, and hydrophobicity. These properties help reduce irritation and minimize friction, improving patient comfort—especially important for prolonged use in clinical settings like hospitals or urology clinics.

• Is this catheter intended for single-use or can it be reused? How does that affect its sterility?

  The AMSURE Foley Catheter is explicitly designed for single-use only and is supplied sterile. This ensures patient safety by preventing cross-contamination and maintaining hygiene standards, which is critical for urinary drainage procedures.

• What French sizes and balloon capacities are available for this catheter, and how do I determine the right fit for a patient?

  The AMSURE Foley Catheter is available in multiple French sizes and balloon capacities, though exact measurements are not specified in the data. Typically, these catheters come in sizes ranging from 8Fr to 30Fr (or higher) to accommodate different patient anatomies. Consulting clinical guidelines or manufacturer packaging for size recommendations based on patient age, gender, and medical condition is advised.

• How should this catheter be stored, and what precautions should be taken to maintain its sterility?

  Since the AMSURE Foley Catheter is supplied sterile, it should be stored in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise sterility before use.

• What regulatory pathways does this device follow, and how does that affect its use in clinical settings?

  The AMSURE Foley Catheter is regulated under FDA 510K clearance and the MDD (Medical Device Directive), adhering to Class II standards for retention catheters. This means it has undergone rigorous review for safety and performance, ensuring compliance with U.S. and EU medical device regulations before clinical use.