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

Clearance details

Applicant

Care Fusion

Product code

Code KNW

Device class

Class 2

Regulation

21 CFR 876.1075

Advisory panel

Gastroenterology, Urology

Date received

2017-05-25

Decision date

2017-09-11

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Vernon Hills, IL, US

• K260517 — Automatic Core Biopsy Instrument2026-08-28
• K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
• K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
• K260572 — Marrow Marxman2026-08-04
• K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

• K233021 — BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device2024-03-06
• K231888 — BD Texium Needle-Free Syringe2023-09-25
• K221319 — BD Alaris Pump Epidural Infusion Set2023-07-21
• K221327 — BD Alaris Pump Infusion Sets2023-07-21
• K223101 — BD Secondary Infusion Set2023-05-12

Death

9

Injury

965

Malfunction

10,444

Other

3

Total

11,421

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0153-2022 — Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration Needle (Adjustable Length 15/16" -1-7/8") (24mm-48mm) sterile, For Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion. Original Jamshidi" Bone Marrow Biopsy/Aspiration Needle: - also referred to as Jamshidi needle Intended use for the posterior iliac crest biopsy techniqueClass II·Terminated·Bard Peripheral Vascular Inc·20210824
• Z-0154-2022 — Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration needle, sterile, Qty: 10, Single Use Only, RX only. Exp. Date Lidocaine Vendor lot. CareFusion Intended use to aspirate marrow from either the sternum or the iliac crest. Intraosseous Infusion is recommended only in life-threatening emergencies where vascular access is critical and conventional forms of access are not available or are unobtainable.Class II·Terminated·Bard Peripheral Vascular Inc·20210824
• Z-2247-2021 — TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;Class II·Ongoing·Bard Peripheral Vascular Inc·20210623
• Z-2248-2021 — EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cmClass II·Ongoing·Bard Peripheral Vascular Inc·20210623
• Z-1689-2020 — Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile - Product Code: DJ4011X - Product Usage: The device is comprised of an outer cannula with a handle and an inner stylet. Its intended use is for the posterior iliac crest biopsy technique.Class II·Terminated·Bard Peripheral Vascular Inc·20200317
• Z-2411-2019 — 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number: TMJ4008Class II·Terminated·Becton Dickinson & Company·20190801

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171531.