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FDA 510(k)

SurGuard3 Safety Hypodermic Needle

K-Number: K212095 · 2022-08-22

ApplicantTerumo Europe N.V.
Decision Date2022-08-22
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SurGuard3 Safety Hypodermic Needle is a medical device manufactured by Terumo Europe N.V.. It received FDA 510(k) clearance on 2022-08-22 under approval number K212095. 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 SurGuard3 Safety Hypodermic Needle?

SurGuard3 Safety Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Terumo Europe N.V.. The 510(k) number is K212095.

When was SurGuard3 Safety Hypodermic Needle approved by the FDA?

SurGuard3 Safety Hypodermic Needle received FDA 510(k) clearance on 2022-08-22, under approval number K212095.

What company makes SurGuard3 Safety Hypodermic Needle?

SurGuard3 Safety Hypodermic Needle is manufactured by Terumo Europe N.V..

What is the FDA product code for SurGuard3 Safety Hypodermic Needle?

The FDA product code for SurGuard3 Safety Hypodermic Needle is FMI.

Related Clinical Trials

NCT07383870 Clinical Evaluation of an AI- and Ultrasound-Assisted Venipuncture Device COMPLETED NCT06000540 Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects NOT_YET_RECRUITING NCT06204614 Drug Screening Using IMD in Bladder Cancer ENROLLING_BY_INVITATION NCT07540806 Ultrasound-Guided Percutaneous Needle Tenotomy (PNT) vs Percutaneous Ultrasonic Needle Tenotomy (PUT) for Gluteal Tendinosis NOT_YET_RECRUITING NCT05231278 Confocal Laser Endomicroscopy Nodule Localization by Robotic Bronchoscopy COMPLETED NCT04766684 Clubfoot Tenotomy Trial COMPLETED

Related PubMed Literature

PMID: 41477286 Comparison of the Safety and Efficacy of Biodegradable Microneedle Acupuncture and Sterile Acupuncture: study protocol for a prospective, confirmatory, superiority, multicenter, parallel, single-blinded randomized controlled trial. Journal of pharmacopuncture (2025)

Other Devices by Terumo Europe N.V.

K161606Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH K192057K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall K230951Terumo Injection Filter Needle (NF-3013RBKE05M) K251447K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) K24330927G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) K243581K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

View all 7 devices →

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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