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FDA 510(k)

Disposable Medical Safety Hypodermic Needle

K-Number: K220603 · 2022-08-23

ApplicantHantech Medical Device Co., Ltd.
Decision Date2022-08-23
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Safety Hypodermic Needle is a medical device manufactured by Hantech Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2022-08-23 under approval number K220603. 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 Disposable Medical Safety Hypodermic Needle?

Disposable Medical Safety Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2022-08-23. It is manufactured by Hantech Medical Device Co., Ltd.. The 510(k) number is K220603.

When was Disposable Medical Safety Hypodermic Needle approved by the FDA?

Disposable Medical Safety Hypodermic Needle received FDA 510(k) clearance on 2022-08-23, under approval number K220603.

What company makes Disposable Medical Safety Hypodermic Needle?

Disposable Medical Safety Hypodermic Needle is manufactured by Hantech Medical Device Co., Ltd..

What is the FDA product code for Disposable Medical Safety Hypodermic Needle?

The FDA product code for Disposable Medical Safety Hypodermic Needle is FMI.

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42174919 Automating Safety Surveillance for Software-Based Medical Devices: Insights from FDA MAUDE Data. Studies in health technology and informatics (2026) PMID: 42065230 The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes. EFORT open reviews (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026)

Other Devices by Hantech Medical Device Co., Ltd.

K221038Disposable Medical Masks K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) K222739Disposable Insulin Pen Needle K222672Disposable Insulin Syringe

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.

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