FDA 510(k)

I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE

K-Number: K120002 · 2012-06-26

ApplicantBusse Hospital Disposables, Inc.

Decision Date2012-06-26

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Busse Hospital Disposables, Inc.. It received FDA 510(k) clearance on 2012-06-26 under 510(k) number K120002. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE?

I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE is a medical device that received FDA 510(k) clearance on 2012-06-26. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K120002.

When did I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE receive FDA 510(k) clearance?

I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE received FDA 510(k) clearance on 2012-06-26, under 510(k) number K120002.

Who is the listed applicant for I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE?

The FDA 510(k) record lists Busse Hospital Disposables, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE?

The FDA product code for I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE is KNW.

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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.