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Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use

by Shanghai Kohope Medical Devices Co., Ltd

510(k) K190002

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 NumberK190002 Date12 Sep 2019ClearedStatusActive

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  • Withdrawn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
Shanghai Kohope 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, 23 Sep 2026

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

The device is a sterile hypodermic syringe for single use, available with or without a needle, and includes a sterile insulin syringe with needle. It is designed for medical procedures such as insulin injections and vaccinations.

The device is sterile and intended for single-use only. It is supplied in various sizes including 1ml U40 with 26G needle (12mm), and is manufactured by Shanghai Kohope Medical Devices Co., Ltd. It has received FDA 510K clearance with product code FMF.