FDA 510(k)

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

K-Number: K181423 · 2018-09-07

Decision Date2018-09-07

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush 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 2018-09-07 under 510(k) number K181423. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Amsino International, Inc.. The 510(k) number is K181423.

When did AMSure Sterile Water, and Sterile Normal Saline for Wound Flush receive FDA 510(k) clearance?

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181423.

Who is the listed applicant for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

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 Sterile Water, and Sterile Normal Saline for Wound Flush?

The FDA product code for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

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Other records listing Amsino International, Inc. as applicant

K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure Enteral Feeding Pump K220267AMSafe NeuFlo Needleless Connector K213522AMSafe Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe

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Related Devices (Code: FRO)

K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261638Bonvadis®Oneness Biotech Co., Ltd.K254073StatSeal DiscMerit Medical Systems, Inc.

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.