FDA 510(k)

29G AND 30G K-PACK II NEEDLE

K-Number: K062608 · 2006-09-15

Decision Date2006-09-15

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

29G AND 30G K-PACK II NEEDLE 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 2006-09-15 under 510(k) number K062608. 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 29G AND 30G K-PACK II NEEDLE?

29G AND 30G K-PACK II NEEDLE is a medical device that received FDA 510(k) clearance on 2006-09-15. The listed applicant is Terumo Europe N.V.. The 510(k) number is K062608.

When did 29G AND 30G K-PACK II NEEDLE receive FDA 510(k) clearance?

29G AND 30G K-PACK II NEEDLE received FDA 510(k) clearance on 2006-09-15, under 510(k) number K062608.

Who is the listed applicant for 29G AND 30G K-PACK II NEEDLE?

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 29G AND 30G K-PACK II NEEDLE?

The FDA product code for 29G AND 30G K-PACK II NEEDLE is FMI.

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Other records listing Terumo Europe N.V. as applicant

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)K230951Terumo Injection Filter Needle (NF-3013RBKE05M)K212095SurGuard3 Safety Hypodermic Needle 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

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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.