Biopsy Handy, MRI Biopsy Handy
FDA 510(k) K102771 · Somatex Medical Technologies GmbH
510(k) numberK102771
Submission
- Device name
- Biopsy Handy, MRI Biopsy Handy
- Applicant
- Somatex Medical Technologies GmbH
Cambridge, MA, US - Received
- September 24, 2010
- Decision date
- June 24, 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 |
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| K182082 | Tumark for Eviva, Tumark for BreveraNEU · Traditional | 10/31/2018SE |
| K180443 | Tumark VisionNEU · Special | 03/22/2018SE |
| K111692 | Tumark Flex for Mammotome,Tumark Flex for AtecNEU · Special | 11/08/2011SE |
| K093064 | Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560NEU · Traditional | 02/17/2010SE |
| K073095 | Tumark Professional, Model 271560; Mr- Tumark Professional, Model 601560NEU · Traditional | 03/19/2008SE |
Questions and answers
When was Biopsy Handy, MRI Biopsy Handy cleared by the FDA?
Biopsy Handy, MRI Biopsy Handy (K102771) received a 510(k) decision of Substantially Equivalent on June 24, 2011, 273 days after the submission was received.
What is the product code of K102771?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.