FDA 510(k)

SureFine Pen Needle

K-Number: K250658 · 2025-04-03

Decision Date2025-04-03

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SureFine Pen Needle is a medical device manufactured by Shina Med Corporation. It received FDA 510(k) clearance on 2025-04-03 under approval number K250658. 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 SureFine Pen Needle?

SureFine Pen Needle is a medical device that received FDA 510(k) clearance on 2025-04-03. It is manufactured by Shina Med Corporation. The 510(k) number is K250658.

When was SureFine Pen Needle approved by the FDA?

SureFine Pen Needle received FDA 510(k) clearance on 2025-04-03, under approval number K250658.

What company makes SureFine Pen Needle?

SureFine Pen Needle is manufactured by Shina Med Corporation.

What is the FDA product code for SureFine Pen Needle?

The FDA product code for SureFine Pen Needle is FMI.

Other Devices by Shina Med Corporation

K152879Sure-Fine Insulin Syringes K152877SureFine Pen Needle K191531Sure-Fine Insulin Syringes K210848Sure-Fine Insulin Syringes K231165Shina Syringe; Shina Safety Syringe K250510Sure-Fine Insulin Syringes

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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.