Mammotome Revolve
Mammotome revolve is a vacuum-assisted breast biopsy system that obtains tissue for histological examination. A sterile single-use probe works with a reusable motor-driven holster and…
Mammotome revolve is a vacuum-assisted breast biopsy system that obtains tissue for histological examination. A sterile single-use probe works with a reusable motor-driven holster and reusable control unit.
Vacuum draws tissue into the probe, where a rotating and translating cutter removes samples. The probe includes the biopsy needle, cutting element, collection chambers and vacuum tubing or valves.
Listed Item
Revolve EX Ultrasound 8G Probe without Sleeve – CE
Control and Imaging
The holster contains drive motors, gearing and activation switches. The control unit houses the vacuum pump, valve actuators, electronics and touchscreen. The system supports stereotactic and ultrasound-guided workflows, with probe guides and optional remote or footswitch controls.
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Curaway Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Plexus (Xiamen) Co., Ltd., | Xiamen | Fujian | Contract manufacturer | 3 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Huanyi Sterilization Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 25 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Carbon (Shenzhen) Medical Device Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Canyon Medical Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Suzhou Leapmed Healthcare Corporation | Suzhou | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Devicor Medical Products, Inc., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K152989 |
| Record published | 2016-10-24 |
| Record revised | 2026-06-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature -18 to 54 °C |
| Packaging | Pack of 5 |
| Sizes | Needle gauge 8 to 10 G; length 9 to 15 cm |
| Distribution end date | 2022-11-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MSCM1 | In distribution | |
| CA000399011 | Needle Gauge 10 G | In distribution |
| CA000399013 | Needle Gauge 8 G | In distribution |
| CA000399015 | Needle Gauge 8 G | In distribution |
| CA000399017 | Needle Gauge 10 G | In distribution |
| DIRECT MARK GTIN | In distribution | |
| MFOOT1 | In distribution | |
| CA000507001 | In distribution | |
| MSCM1 | In distribution | |
| MHUSH1 | In distribution | |
| DIRECT MARK GTIN | In distribution | |
| DIRECT MARK | In distribution | |
| DIRECT MARK GTIN | In distribution | |
| MSTH1 | In distribution | |
| CA000399010 | Needle Gauge 10 G | In distribution |
| CA000400003 | Needle Gauge 8 G | In distribution |
| CA000399018 | Needle Gauge 10 G | In distribution |
| CA00006003 | In distribution | |
| MHKEYP1 | In distribution | |
| CA000460002 | In distribution | |
| CA000399014 | Needle Gauge 8 G | In distribution |
| CA000399016 | Needle Gauge 10 G | In distribution |
| CA000400004 | Needle Gauge 10 G | In distribution |
| CA000399012 | Needle Gauge 10 G | In distribution |
| MCART1 | In distribution | |
| MST1012 | Length 12 cm | Withdrawn |
| MST1009 | Length 9 cm | Withdrawn |
| CA000399009 | Needle Gauge 8 G | Withdrawn |
| MST0815 | Length 15 cm | Withdrawn |
| CA000399008 | Needle Gauge 8 G | Withdrawn |
| MST0809 | Length 9 cm | Withdrawn |
| CA000399007 | Needle Gauge 8 G | Withdrawn |
| MST1015 | Length 15 cm | Withdrawn |
| MHUS08 | Needle Gauge 8 G | Withdrawn |
| MST0812 | Length 12 cm | Withdrawn |
| MHUS10 | Needle Gauge 10 G | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Curaway | Zhejiang Curaway Medical Technology Co., Ltd. | 910 |
| SureAim Coaxial Biopsy Needle | Canyon Medical Inc. | 157 |
| CorVocet™ | Merit Medical Systems, Inc. | 157 |
| SureCore Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 156 |
| M Biopsy Automatic Disposable Biopsy Needle | Canyon Medical Inc. | 108 |
| M Biopsy Coaxial Biopsy Needle | Canyon Medical Inc. | 89 |
| Co-Axial Introducer Needle | Argon Medical Devices, Inc. | 80 |
| SureCore Semi-automatic Disposable Biopsy Needle | Canyon Medical Inc. | 76 |
| Invivo | Philips DS North America LLC | 71 |
| Coaxial needle | Möller Medical GmbH | 68 |
| Disposable needle for reusable biopsy gun | Möller Medical GmbH | 62 |
| Remington Medical, Inc. Automatic Cutting Needle (NAC) | Remington Medical, Inc. | 60 |
Showing 12 of 692. All products under Instrument, Biopsy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260365 | 2026-03-04 |
| K243095 | 2024-10-29 |
| K202012 | 2020-08-18 |
| K153709 | 2016-08-08 |
| K152989 | 2016-02-25 |
| K123259 | 2012-11-15 |
| K112411 | 2012-03-20 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Devicor Medical Products, Inc. | 510(k) number | 2017-02-28 | Class II | Process control | The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number. | 320 | 2017-08-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.