FDA 510(k)

Terumo Injection Filter Needle (NF-3013RBKE05M)

K-Number: K230951 · 2023-10-18

Decision Date2023-10-18

Product CodeQYM

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Terumo Injection Filter Needle (NF-3013RBKE05M) is a medical device manufactured by Terumo Europe N.V.. It received FDA 510(k) clearance on 2023-10-18 under approval number K230951. The device is classified under product code QYM. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Terumo Injection Filter Needle (NF-3013RBKE05M)?

Terumo Injection Filter Needle (NF-3013RBKE05M) is a medical device that received FDA 510(k) clearance on 2023-10-18. It is manufactured by Terumo Europe N.V.. The 510(k) number is K230951.

When was Terumo Injection Filter Needle (NF-3013RBKE05M) approved by the FDA?

Terumo Injection Filter Needle (NF-3013RBKE05M) received FDA 510(k) clearance on 2023-10-18, under approval number K230951.

What company makes Terumo Injection Filter Needle (NF-3013RBKE05M)?

Terumo Injection Filter Needle (NF-3013RBKE05M) is manufactured by Terumo Europe N.V..

What is the FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M)?

The FDA product code for Terumo Injection Filter Needle (NF-3013RBKE05M) is QYM.

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

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 K212095SurGuard3 Safety Hypodermic Needle 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)

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Related Devices (Code: QYM)

K242073STERiJECT Ophthalmic Needle; STERiJECT Ophthalmic Needle Low Dead Space (LDS)Tsk Laboratory International Japan KK

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.