Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Mammotome Revolve™ Dual Vacuum-Assisted Biopsy System EUDAMEDMammotome revolve FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- Footswitch EUDAMEDFDA UDI
- Model / Reference
- MFOOT1 EUDAMEDFDA UDI
- Description
- Footswitch FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841911100669 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD02G000003322V4 EUDAMED
- FDA Product Code
- KNW FDA 510(k)FDA UDI
- EMDN Code
- A019012 BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS EUDAMED
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 876.1075 FDA 510(k)
- Regulation Number
- 876.1075 FDA 510(k)FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Mammotome Revolve Dual Vacuum-Assisted Biopsy System is a vacuum-assisted breast biopsy device designed for tissue acquisition in breast procedures. It employs dual vacuum technology to excise targeted tissue samples, enabling precise and controlled removal of lesions or suspicious areas. This system is classified under vacuum-assisted biopsy devices and is intended for stereotactic-guided, ultrasound-guided, or open biopsy procedures in breast tissue. Its automated specimen management enhances sample integrity and organization for pathology review.
The device is supplied as a reusable system with disposable components, including biopsy needles and specimen collection chambers. It is intended for use in clinical settings such as radiology suites, surgical centers, and breast clinics, where MRI safety is not a primary concern. The system includes interchangeable biopsy needles in various gauges and lengths, tailored to different lesion sizes and procedural requirements. Sterility is maintained through single-use disposable components, and proper storage involves keeping the reusable components in a clean, dry environment as per manufacturer guidelines. Authorized for use under FDA 510(k) clearance and MDR compliance, it adheres to regulatory standards for medical devices.
Frequently asked questions
What types of biopsy procedures can the Mammotome Revolve Dual Vacuum Assisted Biopsy System be used for in breast tissue?
The Mammotome Revolve Dual Vacuum Assisted Biopsy System is designed for stereotactic-guided, ultrasound-guided, or open biopsy procedures in breast tissue. Its dual vacuum technology allows precise excision of targeted lesions or suspicious areas, making it versatile for different clinical approaches where MRI safety is not a concern.
Are the biopsy needles included with the Mammotome Revolve system reusable or disposable, and what sizes are available?
The Mammotome Revolve system includes disposable biopsy needles in interchangeable gauges and lengths, tailored to accommodate various lesion sizes and procedural needs. The reusable components of the system (e.g., the core device) require proper cleaning and storage, while the single-use needles ensure sterility for each procedure.
How is sterility maintained when using the Mammotome Revolve Dual Vacuum Assisted Biopsy System, and what storage guidelines apply?
Sterility is maintained through the use of single-use disposable components, including biopsy needles and specimen collection chambers. The reusable parts of the system must be stored in a clean, dry environment as directed by the manufacturer to prevent contamination between uses.
In what clinical settings is the Mammotome Revolve system intended for use, and why?
The system is intended for use in radiology suites, surgical centers, and breast clinics, where MRI safety is not a primary concern. Its design supports precise tissue acquisition for pathology review, making it suitable for environments where breast biopsies are performed under stereotactic, ultrasound, or open guidance.
What regulatory pathways does the Mammotome Revolve Dual Vacuum Assisted Biopsy System follow, and what does that mean for its use?
The system is authorized under FDA 510(k) clearance and MDR compliance, meaning it has undergone regulatory review to demonstrate substantial equivalence to prior-generation devices. This clearance allows clinicians to use it with confidence that it meets established safety and performance standards for vacuum-assisted breast biopsy procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mammotome Revolve™ Vacuum-Assisted Breast Biopsy System| Mammotome, PDF Mammotome Revolve™ dual vacuum-assisted breast biopsy system for, Mammotome Revolve™ Biopsy System | Mammotome
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K202012 | Class II | Active |
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Manufacturer
- Manufacturer
- Devicor Medical Products, Inc.
Sources (3)
- FDA 510(k) K202012 24 fields · synced Oct 6, 2026
- FDA UDI 1d11e92c-aa4e-4fdc-ba37-b132186d38ad 36 fields · synced May 30, 2026
- EUDAMED 1c4c6e44-a00c-4090-b35a-252c485ff0a0 61 fields · synced Jul 15, 2026