Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Injection Pen Needle

K-Number: K192464 · 2020-08-25

ApplicantGangan Medical Technology Jiangsu Co., Ltd.
Decision Date2020-08-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Injection Pen Needle is a medical device manufactured by Gangan Medical Technology Jiangsu Co., Ltd.. It received FDA 510(k) clearance on 2020-08-25 under approval number K192464. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Injection Pen Needle?

Injection Pen Needle is a medical device that received FDA 510(k) clearance on 2020-08-25. It is manufactured by Gangan Medical Technology Jiangsu Co., Ltd.. The 510(k) number is K192464.

When was Injection Pen Needle approved by the FDA?

Injection Pen Needle received FDA 510(k) clearance on 2020-08-25, under approval number K192464.

What company makes Injection Pen Needle?

Injection Pen Needle is manufactured by Gangan Medical Technology Jiangsu Co., Ltd..

What is the FDA product code for Injection Pen Needle?

The FDA product code for Injection Pen Needle is FMI.

Related Clinical Trials

NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED NCT06606587 Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia COMPLETED NCT07548892 Comparison of Needle-Free Injection and Conventional Syringe for Tooth Extractions in Children NOT_YET_RECRUITING NCT07542132 The Effects of Hyaluronic Acid on Skin Health NOT_YET_RECRUITING

Related Devices (Code: FMI)

K162516BD Pen NeedleBecton, Dickinson and Company K160532Greiner HoldexGreiner Bio-One Na, Inc. K160199Advocate Insulin Pen NeedlesDiabetic Supply of Suncoast, Inc. K151090CPL Insulin Pen NeedleCpl Co., Ltd. K160575CareSens Pen Needle, Softip Pen NeedleYidobio, Inc. K153706Insulin Pen NeedleSteriLance Medical (Suzhou), Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑