FDA 510(k)

CYTOSAFE NEEDLE

K-Number: K844904 · 1985-02-22

ApplicantBaxa Corp., Sub. of Cook Group, Inc.

Decision Date1985-02-22

Product CodeLHI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

CYTOSAFE NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. It received FDA 510(k) clearance on 1985-02-22 under 510(k) number K844904. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOSAFE NEEDLE?

CYTOSAFE NEEDLE is a medical device that received FDA 510(k) clearance on 1985-02-22. The listed applicant is Baxa Corp., Sub. of Cook Group, Inc.. The 510(k) number is K844904.

When did CYTOSAFE NEEDLE receive FDA 510(k) clearance?

CYTOSAFE NEEDLE received FDA 510(k) clearance on 1985-02-22, under 510(k) number K844904.

Who is the listed applicant for CYTOSAFE NEEDLE?

The FDA 510(k) record lists Baxa Corp., Sub. of Cook Group, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CYTOSAFE NEEDLE?

The FDA product code for CYTOSAFE NEEDLE is LHI.

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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.