Identity
- Trade Name
- Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System EUDAMEDMammotome revolve FDA UDI
- Generic Name
- Mammographic stereotactic biopsy system FDA UDI
- Device Name
- Holster EUDAMEDUltrasound Holster - CE FDA UDI
- Model / Reference
- MHUSH1 EUDAMEDFDA UDI
- Description
- Ultrasound Holster - CE FDA UDI
Identifiers
- Catalog Number
- MHUSH1 FDA UDI
- Primary DI / UDI-DI
- 00841911100683 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD02B000003322QK EUDAMED
- 510(k) Number
- K152989 FDA UDI
- FDA Product Code
- KNW 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 IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1075 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- 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
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Mammographic stereotactic biopsy system
Mammotome revolve by Devicor Medical Products, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mammographic stereotactic biopsy system.
- ATEC SAPPHIRE 100 — Hologic, Inc. · Class II
- Brevera Breast Biopsy System — Hologic, Inc. · Class II
- BIOPSY DIGIT — I.M.S. INTERNAZIONALE MEDICO SCIENTIFICA SRL · Class II
- Brevera Breast Biopsy System — Hologic, Inc. · Class II
- Eviva — Hologic, Inc. · Class I
- ENCOR® — SENORX, INC. · Class II
- Affirm Breast Biopsy Guidance System — Hologic, Inc. · Class II
- ENCOR® — SENORX, INC. · Class II
Cleared under the same submission
K152989 also covers:
- Mammotome Revolve — Devicor Medical Products, Inc.
- Mammotome Revolve EX — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
- Mammotome revolve — Devicor Medical Products, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Devicor Medical Products, Inc.
Sources (2)
- FDA UDI 43b1701a-63db-4a3f-8097-c529313d3f1f 37 fields · synced Jul 20, 2026
- EUDAMED cdf56816-18b3-4d70-bda0-211aa2169902 61 fields · synced Jul 20, 2026