Mammotome Elite Biopsy System
FDA 510(k) K112411 · Devicor Medical Products, Inc.
510(k) numberK112411
Submission
- Device name
- Mammotome Elite Biopsy System
- Applicant
- Devicor Medical Products, Inc.
Cincinnati, OH, US - Received
- August 22, 2011
- Decision date
- March 20, 2012
- 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
Other 510(k)s with product code KNW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | 03/04/2026SE |
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | 01/23/2026SE |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy SystemKNW · Traditional | 10/29/2024SE |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)NEU · Traditional | 07/10/2024SE |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker…NEU · Traditional | 01/12/2024SE |
| K221961 | HydroMARK Plus Breast Biopsy Site MarkerNEU · Traditional | 07/13/2023SE |
| K212158 | HydroMARK Breast Biopsy Site MarkerNEU · Traditional | 04/21/2022SE |
| K210752 | HydroMARK Breast Biopsy Site MarkerNEU · Special | 04/14/2021SE |
| K203097 | HydroMARK Breast Biopsy Site MarkersNEU · Traditional | 12/16/2020SE |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemKNW · Traditional | 08/18/2020SE |
Questions and answers
When was Mammotome Elite Biopsy System cleared by the FDA?
Mammotome Elite Biopsy System (K112411) received a 510(k) decision of Substantially Equivalent on March 20, 2012, 211 days after the submission was received.
What is the product code of K112411?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.