Hantech Pre-filled 0.9% Normal Saline Flush Syringes - 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Withdrawn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)

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

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