FDA 510(k)

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)

K-Number: K243309 · 2025-05-29

Decision Date2025-05-29

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) 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 2025-05-29 under 510(k) number K243309. 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 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)?

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) is a medical device that received FDA 510(k) clearance on 2025-05-29. The listed applicant is Terumo Europe N.V.. The 510(k) number is K243309.

When did 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) receive FDA 510(k) clearance?

27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) received FDA 510(k) clearance on 2025-05-29, under 510(k) number K243309.

Who is the listed applicant for 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)?

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 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)?

The FDA product code for 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) 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.