Mammotome MR
Universal Biopsy Procedure Kit - Short with Targeting Set
9manufacturers in China registered for this device type
20catalogue 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) | K042753 |
| Record published | 2022-02-07 |
| Record revised | 2026-06-19 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Needle gauge 8 to 11 G; length 115 to 145 mm; height 115 mm |
| Distribution end date | 2022-02-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MRT11X | Length 145 mm | In distribution |
| MRT08X | Length 145 mm | In distribution |
| MRU08S | Length 115 mm | In distribution |
| MRT11S | Length 115 mm | In distribution |
| MRU11S | Length 115 mm | In distribution |
| MRU11X | Length 145 mm | In distribution |
| MRT08S | Height 115 mm | In distribution |
| MRP11X | Length 145 mm | In distribution |
| MRP11S | Length 115 mm | In distribution |
| MRU08X | Length 145 mm | In distribution |
| MRP08X | Length 145 mm | In distribution |
| MRP08S | Length 115 mm | In distribution |
| MUK301 | Needle Gauge 11 G | Withdrawn |
| MUK302 | Needle Gauge 11 G | Withdrawn |
| MUK304 | Needle Gauge 8 G | Withdrawn |
| MRK303 | Needle Gauge 8 G | Withdrawn |
| MRK301 | Needle Gauge 11 G | Withdrawn |
| MRK304 | Needle Gauge 8 G | Withdrawn |
| MRK302 | Needle Gauge 11 G | Withdrawn |
| MUK303 | Needle Gauge 8 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
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.