Mammotome Elite
Holster (tetherless vacuum-assisted biopsy system) - Refresh - CE
9manufacturers in China registered for this device type
9catalogue numbers in this listing
7510(k) clearances naming this product code
1recall
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) | K153709 |
| Record published | 2022-02-04 |
| 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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment temperature -20 to 50 °C; Handling environment atmospheric pressure 500 to 1060 KiloPascal; Handling environment humidity 10 to 95 % RH |
| Packaging | Pack of 5 |
| Sizes | Needle gauge 10 to 13 G; length 13.4 to 13.6 cm |
| Distribution end date | 2025-07-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MEI13 | Needle Gauge 13 G | In distribution |
| CA000137013 | Length 13.4 cm | In distribution |
| MEI10 | Needle Gauge 10 G | In distribution |
| CA000137012 | Length 13.6 cm | In distribution |
| DIRECT MARK | In distribution | |
| MEH1 | In distribution | |
| CA000687001 | In distribution | |
| MEP10 | Length 13.4 cm | Withdrawn |
| MEP13 | Length 13.6 cm | 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
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 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.