NovaCore Semi-Automatic Biopsy Instrument
FDA 510(k) K213232 · Argon Medical Devices
510(k) numberK213232
Submission
- Device name
- NovaCore Semi-Automatic Biopsy Instrument
- Applicant
- Argon Medical Devices
Athens, TX, US - Received
- September 30, 2021
- Decision date
- July 1, 2022
- 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 |
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| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
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| 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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| K241145 | TLAB® Transvenous Liver Biopsy System (TF-18C)DYB · Traditional | 08/01/2024SE |
| K233909 | Cleaner Plus 18F Thrombectomy System - Cleaner Plus 18F Aspiration Catheter, Cleaner…QEW · Traditional | 03/28/2024SE |
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Questions and answers
When was NovaCore Semi-Automatic Biopsy Instrument cleared by the FDA?
NovaCore Semi-Automatic Biopsy Instrument (K213232) received a 510(k) decision of Substantially Equivalent on July 1, 2022, 274 days after the submission was received.
What is the product code of K213232?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.