FDA 510(k)

ONE.CLICK NEEDLE

K-Number: K033575 · 2004-02-09

Decision Date2004-02-09

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ONE.CLICK NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2004-02-09 under 510(k) number K033575. 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 ONE.CLICK NEEDLE?

ONE.CLICK NEEDLE is a medical device that received FDA 510(k) clearance on 2004-02-09. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K033575.

When did ONE.CLICK NEEDLE receive FDA 510(k) clearance?

ONE.CLICK NEEDLE received FDA 510(k) clearance on 2004-02-09, under 510(k) number K033575.

Who is the listed applicant for ONE.CLICK NEEDLE?

The FDA 510(k) record lists B.Braun Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ONE.CLICK NEEDLE?

The FDA product code for ONE.CLICK NEEDLE 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.