Identity
- Trade Name
- Mammotome Revolve™ Dual Vacuum-Assisted Breast Biopsy System EUDAMEDMammotome revolve FDA UDI
- Generic Name
- Side-notch biopsy gun handpiece/needle FDA UDI
- Device Name
- Probe EUDAMEDUltrasound Probe - Non-Glass Falcon - CE FDA UDIUltrasound Probe - CE FDA UDI
- Model / Reference
- MHUS10 EUDAMEDFDA UDI
- Description
- Ultrasound Probe - Non-Glass Falcon - CE FDA UDIUltrasound Probe - CE FDA UDI
Identifiers
- Catalog Number
- CA000400004 FDA UDIMHUS10 FDA UDI
- Primary DI / UDI-DI
- 00841911102762 EUDAMEDFDA UDI00841911100829 EUDAMEDFDA UDI
- Basic UDI-DI
- 08419111AD02C000003322RG 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
- Side-notch biopsy gun handpiece/needle 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 UDINot 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
Dimensions & Sizes
- Size
- Needle Gauge — 10 Gauge FDA UDI
Category: Side-notch biopsy gun handpiece/needle
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 Side-notch biopsy gun handpiece/needle.
- M-Biopsy — Mermaid Medical A/S · Class II
- Disposable Automatic Biopsy Gun — Möller Medical GmbH · Class II
- Disposable Semi-Automatic Biopsy Gun — Möller Medical GmbH · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- MONOPTY — Bard Peripheral Vascular · Class II
- M-Biopsy — Mermaid Medical A/S · Class II
- TOP CUT — H.S. HOSPITAL SERVICE SPA · Class II
- M-Biopsy — Mermaid Medical A/S · 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
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
- Devicor Medical Products, Inc.
Sources (4)
- FDA UDI 8aa39a45-2e9e-4619-b238-362a25e4aab9 36 fields · synced Jul 11, 2026
- FDA UDI 6158a0cb-d09a-4fad-be8e-903b4ae9cd64 38 fields · synced May 30, 2026
- EUDAMED ec816d68-5b71-40cc-b38b-664de6a10886 61 fields · synced Jun 19, 2026
- EUDAMED 6296c4e3-8073-4b18-b095-7aa7687e5613 61 fields · synced Jul 11, 2026