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)

Well-life TM Pen Needles, Well-life TM Safety Pen Needles

K-Number: K210748 · 2022-05-25

ApplicantW. L. Med Co., Ltd.
Decision Date2022-05-25
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Well-life TM Pen Needles, Well-life TM Safety Pen Needles is a medical device manufactured by W. L. Med Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under approval number K210748. 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 Well-life TM Pen Needles, Well-life TM Safety Pen Needles?

Well-life TM Pen Needles, Well-life TM Safety Pen Needles is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by W. L. Med Co., Ltd.. The 510(k) number is K210748.

When was Well-life TM Pen Needles, Well-life TM Safety Pen Needles approved by the FDA?

Well-life TM Pen Needles, Well-life TM Safety Pen Needles received FDA 510(k) clearance on 2022-05-25, under approval number K210748.

What company makes Well-life TM Pen Needles, Well-life TM Safety Pen Needles?

Well-life TM Pen Needles, Well-life TM Safety Pen Needles is manufactured by W. L. Med Co., Ltd..

What is the FDA product code for Well-life TM Pen Needles, Well-life TM Safety Pen Needles?

The FDA product code for Well-life TM Pen Needles, Well-life TM Safety Pen Needles is FMI.

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT03228641 Evaluation of Safety and Efficacy of Micro-coring Device for Treatment of Facial Wrinkles and Skin Laxity COMPLETED

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.

↑