Bone Marrow Aspiration Needle, Model BMB1110J, Bone Marrow Harvest Needle, Model BMHN1104VX, & Bone Marrow Biopsy Needl
FDA 510(k) K020867 · Worldwide Medical Technologies, LLC
510(k) numberK020867
Submission
- Device name
- Bone Marrow Aspiration Needle, Model BMB1110J, Bone Marrow Harvest Needle, Model BMHN1104VX, & Bone Marrow Biopsy Needl
- Applicant
- Worldwide Medical Technologies, LLC
Woodbury, CT, US - Received
- March 18, 2002
- Decision date
- May 20, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
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Questions and answers
When was Bone Marrow Aspiration Needle, Model BMB1110J, Bone Marrow Harvest Needle, Model BMHN1104VX, & Bone Marrow Biopsy Needl cleared by the FDA?
Bone Marrow Aspiration Needle, Model BMB1110J, Bone Marrow Harvest Needle, Model BMHN1104VX, & Bone Marrow Biopsy Needl (K020867) received a 510(k) decision of Substantially Equivalent on May 20, 2002, 63 days after the submission was received.
What is the product code of K020867?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.