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

by Hantech Medical Device Co., Ltd. 510(k)

Active United States

510(k) K231363

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK231363	Date27 Sep 2023Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K231363
FDA Product Code: NGT
Models / Variants: PFS-1003
PFS-1005
PFS-1010)

Regulation: 21 CFR Part 880.5200
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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