Cleared Traditional

K171531 - Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow Biopsy/Aspiration Needle, Jamshidi Evolve Bone Marrow Biopsy/Aspiration Needle (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171531 · Care Fusion · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 359
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K171531.
Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module
K260365 · Devicor Medical Products, Inc. · Mar 2026
ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit)
K252795 · Argon Medical Devices, Inc. · Feb 2026
EnCor EnCompass™ Breast Biopsy and Tissue Removal System
K252681 · Bard Peripheral Vascular, Inc. · Dec 2025
Resitu Slider 09 (RESL09)
K252183 · Resitu Medical AB · Sep 2025
Forcyte Autograft Harvest Kit
K243407 · Forcyte Medical, LLC · Jul 2025
Disposable Biopsy Needle
K244018 · Zhejiang Curaway Medical Technology Co., Ltd. · Jul 2025