Sterile Hypodermic Needle for Single Use

by Jiangsu Shenli Medical Production Co., Ltd. China 510(k)

510(k) K180259 Product code FMI

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK180259	Date18 May 2018Cleared	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Withdrawn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) · synced 22 Oct 2026

510(k) Number: K180259
FDA Product Code: FMI

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

Other devices from Jiangsu Shenli Medical Production Co., Ltd.

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Class I
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Class IIa
Sterile Hypodermic Needles for Single Use

Class IIa
Non-sterile Irrigation Syringes for Single Use

Class I
Sterile Syringes without Needles for Single Use

Class I
Sterile Syringes without Needles for Single Use

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See all devices from Jiangsu Shenli Medical Production Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K180259 24 fields · synced 22 Oct 2026