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FDA 510(k)

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)

K-Number: K231363 · 2023-09-27

ApplicantHantech Medical Device Co., Ltd.
Decision Date2023-09-27
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is a medical device manufactured by Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under approval number K231363. 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 Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Hantech Medical Device Co., Ltd.. The 510(k) number is K231363.

When was Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) approved by the FDA?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) received FDA 510(k) clearance on 2023-09-27, under approval number K231363.

What company makes Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is manufactured by Hantech Medical Device Co., Ltd..

What is the FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

The FDA product code for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) is NGT.

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Other Devices by Hantech Medical Device Co., Ltd.

K221038Disposable Medical Masks K220603Disposable Medical Safety Hypodermic Needle K222739Disposable Insulin Pen Needle K222672Disposable Insulin Syringe

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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