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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 the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2018-09-04 under 510(k) 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. The listed applicant is Amsino International, Inc.. The 510(k) number is K181814.

When did AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water receive FDA 510(k) clearance?

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

Who is the listed applicant for AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water?

The FDA 510(k) record lists Amsino International, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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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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