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 the device name listed in this FDA 510(k) record. The listed applicant is Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2023-09-27 under 510(k) 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. The listed applicant is Hantech Medical Device Co., Ltd.. The 510(k) number is K231363.

When did Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) receive FDA 510(k) clearance?

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 510(k) number K231363.

Who is the listed applicant for Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)?

The FDA 510(k) record lists Hantech Medical Device Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.