AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

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 23 Oct 2026.

Generic Name

Catheter/overtube balloon inflator, single-use

Device Name

Pre-filled syringe

Model / Ref / Catalog

CIS1010, CIS1003, CIS1005, 1

Primary DI / UDI-DI

10704411007470 EUDAMED

10704411007487 EUDAMED

10704411007494 EUDAMED

40704411007495 GUDID

40704411007471 GUDID

40704411007488 GUDID

Basic UDI-DI

B-10704411007470, B-10704411007487, B-10704411007494

510(k) Number

K181814 ↗

FDA Product Code

EZL

EMDN Code

A02010702 Prefilled syringes with sterile water

GMDN Term

Catheter/overtube balloon inflator, single-use

Device Class

Class I 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 types of procedures is this pre-filled syringe designed to assist with, and why is sterile water used instead of another fluid?

  This AMSure pre-filled syringe is specifically designed for balloon inflation during catheterization procedures in urological and gastroenterological settings. The syringe delivers sterile water to inflate and secure the balloon within a retention catheter, ensuring proper positioning in the patient’s bladder. Sterile water is used because it minimizes risks like fluid leakage, tissue irritation, or absorption-related complications that could occur with saline or other solutions, while still providing the necessary inflation volume safely.

• Is this syringe single-use, and if so, how does that impact clinical workflow and sterility?

  Yes, the AMSure pre-filled syringe is intended for single-use only. This design eliminates the need for reprocessing, reducing the risk of contamination and cross-infection between patients. Clinically, this simplifies workflow by ensuring immediate readiness for use—no preparation or cleaning is required—while maintaining sterility through gamma irradiation, a validated method for preserving device integrity.

• Are there different sizes or models available, and if so, how would a clinician determine the correct one for their patient?

  The provided data does not specify distinct sizes or models for the AMSure syringe itself, but it is pre-filled to deliver a precise volume of sterile water tailored for balloon inflation in retention catheters. The correct volume is determined by the catheter manufacturer’s specifications for the balloon being inflated. Clinicians should refer to the catheter’s packaging or instructions to confirm compatibility, as the syringe’s volume aligns with standard retention catheter requirements in urology/gastroenterology.

• How should this syringe be stored, and what precautions should be taken to ensure it remains effective?

  The AMSure pre-filled syringe should be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Since it is sterile and gamma-irradiated, it must remain in its original packaging until use to preserve sterility. Avoid exposure to moisture or contaminants, as this could compromise the syringe’s integrity or the sterility of the sterile water. Always check the expiration date before use, as the effectiveness of gamma-irradiated devices can degrade over time.

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

  The AMSure pre-filled syringe is authorized under FDA 510K (Traditional pathway) and the MDD (Medical Device Directive), classifying it as a Class II device. This means it has undergone rigorous review to demonstrate substantial equivalence to predicate devices, ensuring safety and performance. Clinically, this regulatory clearance confirms the device meets U.S. and EU standards for balloon inflation syringes in urology/gastroenterology, allowing for reliable use in procedures without additional approval requirements beyond standard practice guidelines.