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FDA 510(k)

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water

K-Number: K181814 · 2018-09-04

ApplicantAmsino International, Inc.
Decision Date2018-09-04
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water is a medical device manufactured by Amsino International, Inc.. It received FDA 510(k) clearance on 2018-09-04 under approval number K181814. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water?

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water is a medical device that received FDA 510(k) clearance on 2018-09-04. It is manufactured by Amsino International, Inc.. The 510(k) number is K181814.

When was AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water approved by the FDA?

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water received FDA 510(k) clearance on 2018-09-04, under approval number K181814.

What company makes AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water?

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water is manufactured by Amsino International, Inc..

What is the FDA product code for AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water?

The FDA product code for AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water is EZL.

Related Clinical Trials

NCT05147363 Shockwave: Disruption for A Better Fit WITHDRAWN

Related PubMed Literature

PMID: 41523432 Development of a Low-Cost Portable Iontophoresis Device. Cureus (2025)

Other Devices by Amsino International, Inc.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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