FDA 510(k)

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

K-Number: K243581 · 2025-04-04

Decision Date2025-04-04

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) 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. The listed applicant is Terumo Europe N.V.. The 510(k) number is K243581.

When did K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) receive FDA 510(k) clearance?

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

Who is the listed applicant for K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: FMI)

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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.