FDA 510(k)

I-STYLE BONE MARROW ASPIRATION NEEDLE

K-Number: K061570 · 2006-07-03

ApplicantBusse Hospital Disposables, Inc.

Decision Date2006-07-03

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

I-STYLE BONE MARROW ASPIRATION NEEDLE 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 2006-07-03 under 510(k) number K061570. 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?

I-STYLE BONE MARROW ASPIRATION NEEDLE is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Busse Hospital Disposables, Inc.. The 510(k) number is K061570.

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

I-STYLE BONE MARROW ASPIRATION NEEDLE received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061570.

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

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?

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

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Other records listing Busse Hospital Disposables, Inc. as applicant

K120002I-STYLE BONE MARROW ASPIRATION NEEDLE WITH T-HANDLE K093909BUSSE SURGICAL DRAPES IV K092212BUSSE SURGICAL DRAPES III K082297BUSSE SURGICAL DRAPE K073222MODIFICATION TO:SPECIALTY NEEDLES K070465BUSSE EPIDURAL CATHETER

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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.