Clearview Plus Bone and Vertebral Body Biopsy Needles
FDA 510(k) K022169 · Parallax Medical, Inc.
510(k) numberK022169
Submission
- Device name
- Clearview Plus Bone and Vertebral Body Biopsy Needles
- Applicant
- Parallax Medical, Inc.
Scotts Valley, CA, US - Received
- July 3, 2002
- Decision date
- July 25, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K033230 | Tracers Ta Bone Cement Opacifier, Model Tcr-TaMYU · Special | 12/12/2003SE |
| K023445 | Tracers Bone Cement OpacifierMYU · Special | 03/11/2003SE |
| K011206 | Parallax Bone and Vertebral Body Biopsy and Infusion NeedlesKNW · Abbreviated | 07/18/2001SE |
| K994022 | Parallax CraniosetGXP · Traditional | 08/31/2000SE |
| K991893 | Parallax Tracer Radiopaque ParticlesMYU · Traditional | 08/13/1999SE |
Questions and answers
When was Clearview Plus Bone and Vertebral Body Biopsy Needles cleared by the FDA?
Clearview Plus Bone and Vertebral Body Biopsy Needles (K022169) received a 510(k) decision of Substantially Equivalent on July 25, 2002, 22 days after the submission was received.
What is the product code of K022169?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.