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Sterile Hypodermic Syringe for Single Use

by Jiangsu Jichun Medical Devices CO., Ltd

510(k) K212846

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK212846 Date30 Aug 2022ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMF
FDA applicant
Jiangsu Jichun Medical Devices Co., Ltd.
Device Class
Class II
Regulation
21 CFR Part 880.5860
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

A sterile hypodermic syringe for single use is a medical device designed for the injection or withdrawal of fluids. It is intended for general hospital use and may be supplied with or without a needle.

The device is supplied sterile and is designated for single-use only. It received FDA 510(k) clearance under K212846 on 2022-08-30 and is classified as a Class II device with product code FMF.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Sterile Hypodermic Syringe for Single Use intended for?

    It is designed for the injection or withdrawal of fluids in general hospital settings, and may be used with or without a needle depending on clinical need.

  • Is the syringe sterile and for single use only?

    Yes, the device is supplied sterile and is designated for single-use only to prevent cross-contamination and ensure patient safety.

  • What regulatory clearance does this syringe have?

    It received FDA 510(k) clearance under K212846 on August 30, 2022, and is classified as a Class II device with product code FMF.

  • Who manufactures this syringe and where are they located?

    The syringe is manufactured by Jiangsu Jichun Medical Devices Co., Ltd., located at #98, Baiyang Bridge, Zhenglu Town, Tianning, Changzhou, China, postal code 213111.