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FDA 510(k)

AMSafe Pre-Filled Normal Saline Flush Syringe

K-Number: K213522 · 2022-03-22

ApplicantAmsino International, Inc.
Decision Date2022-03-22
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

AMSafe Pre-Filled Normal Saline Flush Syringe is a medical device manufactured by Amsino International, Inc.. It received FDA 510(k) clearance on 2022-03-22 under approval number K213522. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMSafe Pre-Filled Normal Saline Flush Syringe?

AMSafe Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by Amsino International, Inc.. The 510(k) number is K213522.

When was AMSafe Pre-Filled Normal Saline Flush Syringe approved by the FDA?

AMSafe Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2022-03-22, under approval number K213522.

What company makes AMSafe Pre-Filled Normal Saline Flush Syringe?

AMSafe Pre-Filled Normal Saline Flush Syringe is manufactured by Amsino International, Inc..

What is the FDA product code for AMSafe Pre-Filled Normal Saline Flush Syringe?

The FDA product code for AMSafe Pre-Filled Normal Saline Flush Syringe is NGT.

Related Clinical Trials

NCT05995340 ELAPR002f Injectable Gel in the Treatment of Atrophic Acne Scars ACTIVE_NOT_RECRUITING NCT02539095 Efficacy of Intra-articular Collagen Injection in Patients With Knee Joint Pain Compared to Normal Saline Injection COMPLETED NCT07534865 Hyperthermia Combined With Hydrogen Peroxide Microneedle Patch for Viral Warts RECRUITING NCT07321704 Effect of Antiseptic Irrigations With 0.05% Chlorhexidine Gluconate (Irrisept) Versus Normal Saline on Fasciocutaneous Flap-Based Closure of Pilonidal Disease RECRUITING

Other Devices by Amsino International, Inc.

K181445AMSure Hydrophilic Intermittent Catheter K181423AMSure Sterile Water, and Sterile Normal Saline for Wound Flush 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

View all 11 devices →

Related Devices (Code: NGT)

K1534810.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company K171109Praxiject 0.9% NaClMedxl, Inc. K1615520.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company K1733480.9% Sodium Chloride Injection, USPMedline Industries, Inc. K1913780.9% Sodium Chloride Injection, USP, Pre-filled COP SyringeMedline Industries, Inc. K183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeAmsino International, 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.

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