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 UDI
- Model / Reference
- MHUS08 EUDAMEDFDA UDI
- Description
- Ultrasound Probe - Non-Glass Falcon - CE FDA UDI
Identifiers
- Catalog Number
- CA000400003 FDA UDI
- Primary DI / UDI-DI
- 00841911102755 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 UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
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
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Needle Gauge — 8 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
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 8c9d6224-637b-4fa7-9d56-4fe208c2c291 36 fields · synced Jun 19, 2026
- EUDAMED 7d7cfaf9-0ee4-44fa-8cb4-9ed9dfb47186 61 fields · synced Jun 19, 2026