meddevicedb.com FDA Device Reference

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

K202319 Class II Traditional
Decision Date
2021-11-12
Sponsor / Applicant
Tianjin Huahong Technology Co., Ltd.

Technical Specification

510(k) Submission ID K202319
Product Code FMI
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.5570
Decision Date 2021-11-12
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) received FDA 510(k) clearance under submission number K202319, sponsored by Tianjin Huahong Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2021-11-12.

Classification & Regulation

This clearance is catalogued under FDA product code FMI and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.