Medone Ultra
Medone Ultra is a disposable, programmable automatic biopsy system for obtaining soft tissue cores for histological examination. Its spring-loaded guillotine mechanism operates with…
Medone Ultra is a disposable, programmable automatic biopsy system for obtaining soft tissue cores for histological examination. Its spring-loaded guillotine mechanism operates with single-hand activation. It is intended for soft tissue sampling and is excluded from bone biopsy.
The range includes needle cannulas from 14 to 20 gauge and lengths from 60 to 200 mm. Different gauges are identified by color. The cannula and mandrel are made from AISI 304 stainless steel, which forms the direct tissue-contacting portion.
Listed Item
Soft tissue programmable automatic biopsy system 14G x 120mm with Coaxial Needle
Sampling and Sterilization
Applications include sampling kidney, liver, prostate, lymph nodes and other soft tissue masses. The devices are sterilized with ethylene oxide and intended for single use. Medone Ultra is the automatic soft tissue model; the associated Medextra model has a separate design and narrower sampling indications.
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 | Medax Srl Unipersonale, Italy |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| 510(k) | K192101 |
| Record published | 2020-05-05 |
| Record revised | 2026-06-08 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MU18100-00 | In distribution | |
| MU12200-00 | In distribution | |
| MU12160-00 | In distribution | |
| MU18160-00 | In distribution | |
| MU20160-00 | In distribution | |
| MU14200-K0 | In distribution | |
| MU16200-00 | In distribution | |
| MU14160-K0 | In distribution | |
| MU20200-00 | In distribution | |
| MU12100-K0 | In distribution | |
| MU16160-00 | In distribution | |
| MU16100-00 | In distribution | |
| MU18250-K0 | In distribution | |
| MU20100-K0 | In distribution | |
| MU12200-K0 | In distribution | |
| MU12100-00 | In distribution | |
| MU14120-00 | In distribution | |
| MU14120-C0 | In distribution | |
| MU12160-K0 | In distribution | |
| MU12120-K0 | In distribution | |
| MU16160-K0 | In distribution | |
| MU14100-K0 | In distribution | |
| MU12120-C0 | In distribution | |
| MU14100-00 | In distribution | |
| MU18160-K0 | In distribution | |
| MU20200-K0 | In distribution | |
| MU16100-K0 | In distribution | |
| MU18200-00 | In distribution | |
| MU14120-K0 | In distribution | |
| MU12120-00 | In distribution | |
| MU18200-K0 | In distribution | |
| MU16200-K0 | In distribution | |
| MU16120-00 | In distribution | |
| MU14200-00 | In distribution | |
| MU18100-K0 | In distribution | |
| MU20160-K0 | In distribution | |
| MU14160-00 | In distribution | |
| MU20100-00 | In distribution |
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 |
|---|---|
| K192101 | 2020-04-02 |
| K192099 | 2020-04-02 |
| K181803 | 2018-10-18 |
| K172344 | 2017-11-13 |
| K142125 | 2015-12-22 |
| K092338 | 2011-05-27 |
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.