FDA 510(k)

TERUMO 30 GAUGE HYPODERMIC NEEDLE

K-Number: K012646 · 2001-08-27

Decision Date2001-08-27

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TERUMO 30 GAUGE HYPODERMIC NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 2001-08-27 under 510(k) number K012646. 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 TERUMO 30 GAUGE HYPODERMIC NEEDLE?

TERUMO 30 GAUGE HYPODERMIC NEEDLE is a medical device that received FDA 510(k) clearance on 2001-08-27. The listed applicant is Terumo Medical Corp.. The 510(k) number is K012646.

When did TERUMO 30 GAUGE HYPODERMIC NEEDLE receive FDA 510(k) clearance?

TERUMO 30 GAUGE HYPODERMIC NEEDLE received FDA 510(k) clearance on 2001-08-27, under 510(k) number K012646.

Who is the listed applicant for TERUMO 30 GAUGE HYPODERMIC NEEDLE?

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

What is the FDA product code for TERUMO 30 GAUGE HYPODERMIC NEEDLE?

The FDA product code for TERUMO 30 GAUGE HYPODERMIC NEEDLE is FMI.

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Related Devices (Code: FMI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.