Cleared Traditional

K171531 - Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle

K171531 is an FDA 510(k) clearance for Jamshidi Bone Marrow Biopsy/Aspiration ..., manufactured by Care Fusion. The device is a Class 2 Gastroenterology & Urology device with product code KNW cleared through the Traditional 510(k) pathway after a 109-day FDA review.

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

K171531 is an FDA 510(k) clearance for the Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow .... Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on September 11, 2017 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Care Fusion devices

FDA 510(k) Submission Details - K171531

510(k) Number K171531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 131d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNW Device Classification - Class 2, Special Controls

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 289
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K171531.
Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
K172344 · Medax Srl Unipersonale · Nov 2017
iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit
K172558 · Stryker Corporation · Oct 2017
Bard Mission Disposable Core Biopsy Instrument
K171953 · Bard Peripheral Vascular, Inc. · Sep 2017
Möller Medical Biopsy Needles and Systems
K162588 · Moller Medical GmbH · Jun 2017
Brevera Biopsy System with Corlumina Imaging Technology
K163052 · Hologic, Inc. · Mar 2017
Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm
K170539 · Avitus Orthopaedics, Inc. · Mar 2017