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FDA 510(k)

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush

K-Number: K181423 · 2018-09-07

ApplicantAmsino International, Inc.
Decision Date2018-09-07
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

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

When was AMSure Sterile Water, and Sterile Normal Saline for Wound Flush approved by the FDA?

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

What company makes AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is manufactured by Amsino International, Inc..

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.

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Other Devices by Amsino International, Inc.

K181445AMSure Hydrophilic Intermittent Catheter K173665AMSafe Sure-Lok Needle-Free Connector K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water K171857AMSure® Enteral Feeding Syringe with ENFit Tip K183473AMSafe(R) Pre-Filled Normal Saline Flush Syringe K200051PUGGLE Enteral Feeding Pump and Feeding Set

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Related Devices (Code: FRO)

K160695Talymed SuspensionMarine Polymer Technologies, Inc. K160872PolyPlex Wound DressingGlobal Health Solutions, LLC K161623Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mLB.Braun Medical, Inc. K152533Xonrid GelHelsinn Healthcare SA K152970Dynarex Xeroform Petrolatum DressingDynarex Corporation K161212Atteris Antimicrobial Skin ProtectantRochal Industries, LLC

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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