Identity
- Trade Name
- Brevera Breast Biopsy System Adapter EUDAMEDBrevera Breast Biopsy System FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- Brevera Breast Biopsy System EUDAMEDA biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system. FDA UDI
- Model / Reference
- BREVADPTR EUDAMEDFDA UDI
- Description
- A biopsy device adapter used to hold the biopsy device in place on a compatible biopsy system. FDA UDI
Identifiers
- Catalog Number
- BREVADPTR FDA UDI
- Primary DI / UDI-DI
- 15420045507807 EUDAMEDFDA UDI
- Basic UDI-DI
- 54200455BREVERASYSTA EUDAMED
- Direct Marketing DI
- 15420045507807 EUDAMED
- 510(k) Number
- K163052 FDA UDI
- FDA Product Code
- KNW FDA UDI
- EMDN Code
- A01020199 NEEDLES AND KITS FOR HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - OTHER EUDAMED
- GMDN Term
- Mammographic stereotactic biopsy system FDA UDI
Classification
- Device Class
- Class IIa 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
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Mammographic stereotactic biopsy system
Brevera Breast Biopsy System 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.
- BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
- ENCOR® — SENORX, INC. · Class II
- Mammotome — Devicor Medical Products, Inc. · Class II
- ENCOR® — SENORX, INC. · Class II
- 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
K163052 also covers:
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
- Brevera Breast Biopsy System — Hologic, Inc.
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 1d702c57-7960-4097-9609-19e3609af308 36 fields · synced Jul 20, 2026
- EUDAMED 9a05f15c-9801-472e-a3e1-1c459499639d 61 fields · synced Jul 20, 2026