Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)

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

510(k) Number

K192681 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sterile Hypodermic Needle for Single Use

  Class IIa

  CE/MDR

• Sterile Enteral syringe

  Class I

  CE/MDR

• Sterile Hypodermic Syringes for single use

  Class IIa

  CE/MDR

• Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle

  Class II

  FDA 510(k) K221247 Active Cleared 1 Nov 2022

• Enteral Feeding Syringes with Enfit Connectors

  Class II

  FDA 510(k) K182649 Active Cleared 9 Nov 2018

• Sterile Disposable Syringe with Safety Needle

  Class II

  FDA 510(k) K211329 Active Cleared 15 Nov 2021

See all devices from Jiangsu Kangbao Medical Equipment Co., Ltd. →