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FDA 510(k)

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)

K-Number: K243581 · 2025-04-04

ApplicantTerumo Europe N.V.
Decision Date2025-04-04
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) is a medical device manufactured by Terumo Europe N.V.. It received FDA 510(k) clearance on 2025-04-04 under approval number K243581. 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 K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)?

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Terumo Europe N.V.. The 510(k) number is K243581.

When was K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) approved by the FDA?

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) received FDA 510(k) clearance on 2025-04-04, under approval number K243581.

What company makes K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)?

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) is manufactured by Terumo Europe N.V..

What is the FDA product code for K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)?

The FDA product code for K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) is FMI.

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 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)

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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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