FDA 510(k)

NEEDLE, ASPIRATION & INJECTION, DISPOSABLE

K-Number: K902422 · 1991-06-06

Decision Date1991-06-06

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NEEDLE, ASPIRATION & INJECTION, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Gainor Medical Europe, Ltd.. It received FDA 510(k) clearance on 1991-06-06 under 510(k) number K902422. 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 NEEDLE, ASPIRATION & INJECTION, DISPOSABLE?

NEEDLE, ASPIRATION & INJECTION, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1991-06-06. The listed applicant is Gainor Medical Europe, Ltd.. The 510(k) number is K902422.

When did NEEDLE, ASPIRATION & INJECTION, DISPOSABLE receive FDA 510(k) clearance?

NEEDLE, ASPIRATION & INJECTION, DISPOSABLE received FDA 510(k) clearance on 1991-06-06, under 510(k) number K902422.

Who is the listed applicant for NEEDLE, ASPIRATION & INJECTION, DISPOSABLE?

The FDA 510(k) record lists Gainor Medical Europe, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEEDLE, ASPIRATION & INJECTION, DISPOSABLE?

The FDA product code for NEEDLE, ASPIRATION & INJECTION, DISPOSABLE 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.