J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula
FDA 510(k) K110883 · Busse Hospital Disposables
510(k) numberK110883
Submission
- Device name
- J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula
- Applicant
- Busse Hospital Disposables
Hauppauge, NY, US - Received
- March 30, 2011
- Decision date
- June 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
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|---|---|---|---|
| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | Hologic, Inc. | 08/12/2026SE |
| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/12/2026SE |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | Argon Medical Devices, Inc. | 02/23/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | Bard Peripheral Vascular, Inc. | 12/12/2025SE |
| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
| K243407 | Forcyte Autograft Harvest KitKNW · Traditional | Forcyte Medical, LLC | 07/29/2025SE |
More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K141285 | Busse Extension SetFPA · Traditional | 02/19/2015SE |
| K120002 | I-Style Bone Marrow Aspiration Needle with T-HandleKNW · Traditional | 06/26/2012SE |
| K093920 | Busse Epidural Catheter KitBSO · Traditional | 08/06/2010SE |
| K093909 | Busse Surgical Drapes IVKKX · Traditional | 05/06/2010SE |
| K092212 | Busse Surgical Drapes IIIKKX · Special | 10/09/2009SE |
| K082297 | Busse Surgical DrapeKKX · Traditional | 12/09/2008SE |
| K073222 | Modification To:Specialty NeedlesBSP · Special | 04/09/2008SE |
| K070465 | Busse Epidural CatheterBSO · Traditional | 07/19/2007SE |
| K063018 | Glass Loss of Resistance SyringeCAZ · Traditional | 01/22/2007SE |
| K061394 | Specialty Needles (Spinal Needle, Pencil Point Spinal Needle, Epidural Needle)BSP · Traditional | 09/06/2006SE |
Questions and answers
When was J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula cleared by the FDA?
J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition Cannula (K110883) received a 510(k) decision of Substantially Equivalent on June 8, 2011, 70 days after the submission was received.
What is the product code of K110883?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.