Cleared Traditional

Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle

K171531 · Care Fusion · Gastroenterology & Urology
Sep 2017
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K171531 is an FDA 510(k) clearance for the Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle, a Instrument, Biopsy (Class II — Special Controls, product code KNW), submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on September 11, 2017, 109 days after receiving the submission on May 25, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1075.

Submission Details

510(k) Number K171531 FDA.gov
FDA Decision Cleared SESE
Date Received May 25, 2017
Decision Date September 11, 2017
Days to Decision 109 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KNW — Instrument, Biopsy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1075

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