Identity
- Trade Name
- ATEC Breast Biopsy and Excision System Remote Tissue Filter Adapter EUDAMEDATEC FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- ATEC and Eviva Breast Biopsy and Excision System - Needle Guides and Tissue Filter EUDAMEDREMOTE TISSUE FILTER ADAPTER FDA UDI
- Model / Reference
- ATEC RTFA EUDAMEDFDA UDI
- Description
- REMOTE TISSUE FILTER ADAPTER FDA UDI
Identifiers
- Catalog Number
- ATEC RTFA FDA UDI
- Primary DI / UDI-DI
- 05420045503178 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455BRSTSNGTFGK EUDAMED
- Direct Marketing DI
- 05420045503178 EUDAMED
- 510(k) Number
- K042290 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A018002 NEEDLE GUIDES EUDAMED
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Mammographic stereotactic biopsy system
Atec by Hologic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mammographic stereotactic biopsy system.
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- EleVation™ — Bard Peripheral Vascular · Class II
- Mammotome elite — Devicor Medical Products, Inc. · Class II
- Mammotome revolve — Devicor Medical Products, Inc. · Class II
- Mammotome MR — Devicor Medical Products, Inc. · Class II
Cleared under the same submission
K042290 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Hologic, Inc.
Sources (2)
- FDA UDI ac573385-9b62-4fdd-8ee2-9d1a10263e8b 36 fields · synced Jul 9, 2026
- EUDAMED adf611f8-3957-4732-88a6-efc70d98a701 61 fields · synced Jul 9, 2026