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FDA 510(k)

Hypodermic Needle-Pro EDGE Safety Device

K-Number: K211634 · 2021-08-26

ApplicantSmiths Medical Asd, Inc.
Decision Date2021-08-26
Product CodeFMI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Hypodermic Needle-Pro EDGE Safety Device is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K211634. 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 Hypodermic Needle-Pro EDGE Safety Device?

Hypodermic Needle-Pro EDGE Safety Device is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K211634.

When did Hypodermic Needle-Pro EDGE Safety Device receive FDA 510(k) clearance?

Hypodermic Needle-Pro EDGE Safety Device received FDA 510(k) clearance on 2021-08-26, under 510(k) number K211634.

Who is the listed applicant for Hypodermic Needle-Pro EDGE Safety Device?

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

What is the FDA product code for Hypodermic Needle-Pro EDGE Safety Device?

The FDA product code for Hypodermic Needle-Pro EDGE Safety Device is FMI.

Other records listing Smiths Medical Asd, Inc. as applicant

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Related Devices (Code: FMI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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