FDA 510(k)

TERUMO SURGUARD 2 SAFETY NEEDLE

K-Number: K031453 · 2003-07-08

Decision Date2003-07-08

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

TERUMO SURGUARD 2 SAFETY 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 2003-07-08 under 510(k) number K031453. 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 SURGUARD 2 SAFETY NEEDLE?

TERUMO SURGUARD 2 SAFETY NEEDLE is a medical device that received FDA 510(k) clearance on 2003-07-08. The listed applicant is Terumo Medical Corp.. The 510(k) number is K031453.

When did TERUMO SURGUARD 2 SAFETY NEEDLE receive FDA 510(k) clearance?

TERUMO SURGUARD 2 SAFETY NEEDLE received FDA 510(k) clearance on 2003-07-08, under 510(k) number K031453.

Who is the listed applicant for TERUMO SURGUARD 2 SAFETY 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 SURGUARD 2 SAFETY NEEDLE?

The FDA product code for TERUMO SURGUARD 2 SAFETY NEEDLE is FMI.

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Other records listing Terumo Medical Corp. as applicant

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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.