Sterile Hypodermic Needles for Single Use

by Zhejiang Kindly Medical Devices Co., Ltd. 510(k)

Active United States

510(k) K223334

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK223334	Date16 Dec 2022Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K223334
FDA Product Code: FMI

Device Class: Class II
Regulation: 21 CFR Part 880.5570
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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