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Hydrophilic Latex Foley Catheter

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K091699Ref AS40008HRef AS42016HRef AS42024HRef AS42028HRef AS41014HRef AS41020HRef AS42018HRef AS43022HRef AS43024HRef AS41018HRef AS41028H

by Amsino International, Inc.

Identity

Trade Name
AMSure® Hydrophilic Latex Foley Catheter EUDAMED
AMSure ® Hydrophilic Latex Foley Catheters FDA UDI
Generic Name
Ureteral catheter FDA UDI
Device Name
Hydrophilic Foley Catheter EUDAMED
Hydrophilic Latex Foley Catheters, 18FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 28FR, 30cc. FDA UDI
Hydrophilic Latex Foley Catheters, 28FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 20FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 8FR., 3cc. FDA UDI
Hydrophilic Latex Foley Catheters, 24FR, 30cc. FDA UDI
Hydrophilic Latex Foley Catheters, 14FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 18FR, 30cc. FDA UDI
Hydrophilic Latex Foley Catheters, 16FR, 30cc. FDA UDI
Model / Reference
AS40008H EUDAMED
AS42016H EUDAMED
AS42024H EUDAMED
AS42028H EUDAMED
AS41014H EUDAMED
AS41020H EUDAMED
AS42018H EUDAMED
AS43022H EUDAMED
AS43024H EUDAMED
AS41018H EUDAMED
AS41028H EUDAMED
1 FDA UDI
Description
Hydrophilic Latex Foley Catheters, 18FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 28FR, 30cc. FDA UDI
Hydrophilic Latex Foley Catheters, 28FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 20FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 8FR., 3cc. FDA UDI
Hydrophilic Latex Foley Catheters, 24FR, 30cc. FDA UDI
Hydrophilic Latex Foley Catheters, 14FR, 5cc. FDA UDI
Hydrophilic Latex Foley Catheters, 18FR, 30cc. FDA UDI
Hydrophilic Latex Foley Catheters, 16FR, 30cc. FDA UDI

Identifiers

Catalog Number
AS40008H FDA UDI
Primary DI / UDI-DI
10704411008965 EUDAMEDFDA UDI
10704411009085 EUDAMEDFDA UDI
10704411009016 EUDAMEDFDA UDI
10704411008972 EUDAMEDFDA UDI
10704411008910 EUDAMEDFDA UDI
10704411009061 EUDAMEDFDA UDI
10704411008941 EUDAMEDFDA UDI
10704411009030 EUDAMEDFDA UDI
10704411009023 EUDAMEDFDA UDI
10704411015840 EUDAMED
10704411015857 EUDAMED
Basic UDI-DI
B-10704411008910 EUDAMED
B-10704411009023 EUDAMED
B-10704411009061 EUDAMED
B-10704411009085 EUDAMED
B-10704411008941 EUDAMED
B-10704411008972 EUDAMED
B-10704411009030 EUDAMED
B-10704411015840 EUDAMED
B-10704411015857 EUDAMED
B-10704411008965 EUDAMED
B-10704411009016 EUDAMED
510(k) Number
K091699 FDA 510(k)FDA UDI
FDA Product Code
EZL FDA 510(k)FDA UDI
EMDN Code
U020201 URETERAL CATHETERS FOR OCCLUSION EUDAMED
GMDN Term
Ureteral catheter FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 876.5130 FDA 510(k)
Regulation Number
876.5130 FDA 510(k)FDA UDI
Market of Registration
Netherlands EUDAMED
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

Yes

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDIFDA UDI

The Hydrophilic Latex Foley Catheter is a retention-type balloon catheter designed for urinary drainage. It features a latex construction with a hydrophilic coating to reduce insertion discomfort and friction, facilitating easier placement in the urethra.

This device is intended for single-use in clinical settings such as hospitals, urology clinics, and emergency care. Supplied sterile and packaged individually, it complies with FDA 510K clearance and MDD regulations. Available in multiple sizes, it must be stored in a clean, dry environment away from direct sunlight. No MRI safety information is specified.

Frequently asked questions

What clinical settings is this catheter designed for and how is it intended to be used?

The AMSURE Hydrophilic Latex Foley Catheter is specifically designed for single-use in clinical settings like hospitals, urology clinics, and emergency care. It is intended for urinary drainage by retaining a balloon within the bladder, ensuring secure placement while minimizing discomfort during insertion due to its hydrophilic coating.

Is this catheter reusable or meant for single-use, and how is it packaged?

This catheter is explicitly designed for single-use only and is supplied sterile, packaged individually to maintain sterility until use. This ensures safety and compliance with clinical best practices for urinary drainage procedures.

What storage conditions should be followed for this catheter to ensure its integrity?

The catheter must be stored in a clean, dry environment away from direct sunlight. Proper storage conditions help preserve its sterility and functionality, ensuring it remains ready for use when needed.

Are there multiple sizes available for this catheter, and how would I determine the correct size for a patient?

Yes, the AMSURE Hydrophilic Latex Foley Catheter is available in multiple sizes, as indicated by the extensive list of registration numbers (e.g., 1000158532, 1825146). The correct size should be selected based on clinical guidelines and patient-specific factors like age, anatomy, and medical history, typically guided by a healthcare provider.

What regulatory pathways does this device follow, and how does that affect its use?

The catheter follows FDA 510(k) clearance and complies with MDD (Medical Device Directive) regulations, confirming its substantial equivalence to existing devices. This means it has undergone regulatory review to ensure safety and performance, but it does not imply any specific clinical indication—only that it meets established standards for urinary drainage catheters.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Amsino International, Inc.

Sources (21)

  • FDA 510(k) K091699 24 fields · synced Oct 6, 2026
  • FDA UDI cc9c5c8e-f30c-41fa-bfe5-92ea0ada1237 34 fields · synced May 22, 2026
  • FDA UDI 6a3bb8ec-df1e-45f8-be7b-14daaaefc21f 35 fields · synced May 30, 2026
  • FDA UDI 58fb68dc-1379-4fed-a4c3-542c2499520e 34 fields · synced May 30, 2026
  • FDA UDI 3d925ca8-a5b1-4d2e-8d54-f7ded76e15ad 34 fields · synced May 30, 2026
  • FDA UDI 0ae1bd85-082a-4a9d-865e-8bd5cf8e238f 35 fields · synced May 30, 2026
  • FDA UDI 20c9d1d7-de58-4173-a1d7-05e777bd1da9 35 fields · synced May 30, 2026
  • FDA UDI 794c7192-c677-402a-be53-408972b3077a 34 fields · synced May 30, 2026
  • FDA UDI 64eca2b0-2fa2-4221-b1da-01dea4288812 34 fields · synced May 30, 2026
  • FDA UDI d392ee89-d294-4dc7-9ee7-328bf5a888b0 34 fields · synced May 30, 2026
  • EUDAMED fcec68b4-ad53-4308-9d1e-ad97d77a1ee0 61 fields · synced Jul 9, 2026
  • EUDAMED 5bc40eee-f960-49b9-9b04-619e5faf152e 61 fields · synced Jul 9, 2026
  • EUDAMED 43e65449-d320-41b3-be8f-982a56f86412 61 fields · synced Jul 10, 2026
  • EUDAMED 7c129b19-b9b9-49ec-879d-0eeecb55b21b 61 fields · synced Jul 11, 2026
  • EUDAMED 7180e517-4771-4412-9388-d7055306bda3 61 fields · synced Jul 14, 2026
  • EUDAMED 993ff75e-6616-4155-910a-246778ba34a2 61 fields · synced Jul 29, 2026
  • EUDAMED 0b8769a8-cc8f-44e8-8821-e3e71f09794d 61 fields · synced Jul 30, 2026
  • EUDAMED 4ee0b967-67a3-486f-ae3b-b2cad8e7e89e 61 fields · synced Aug 1, 2026
  • EUDAMED cd350d68-6a4d-48c9-a6ad-7f7c88d5cb4f 61 fields · synced Aug 2, 2026
  • EUDAMED 53bbe70d-553e-4e9d-a1c5-e75fdf7c4825 61 fields · synced Aug 3, 2026
  • EUDAMED 256911e3-d0ee-46f2-b405-75a1c88a3584 61 fields · synced Aug 3, 2026