FDA 510(k)

K-PACK II NEEDLE- 27G & 30G THIN WALL

K-Number: K110850 · 2011-06-09

Decision Date2011-06-09

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

K-PACK II NEEDLE- 27G & 30G THIN WALL 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 2011-06-09 under 510(k) number K110850. 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 II NEEDLE- 27G & 30G THIN WALL?

K-PACK II NEEDLE- 27G & 30G THIN WALL is a medical device that received FDA 510(k) clearance on 2011-06-09. The listed applicant is Terumo Europe N.V.. The 510(k) number is K110850.

When did K-PACK II NEEDLE- 27G & 30G THIN WALL receive FDA 510(k) clearance?

K-PACK II NEEDLE- 27G & 30G THIN WALL received FDA 510(k) clearance on 2011-06-09, under 510(k) number K110850.

Who is the listed applicant for K-PACK II NEEDLE- 27G & 30G THIN WALL?

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 II NEEDLE- 27G & 30G THIN WALL?

The FDA product code for K-PACK II NEEDLE- 27G & 30G THIN WALL 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.