MED-L
MED-L is a manual bone-marrow biopsy and aspiration system for the posterior iliac crest. An outer cannula with a handle surrounds an inner stylet, forming the needle assembly. A universal…
MED-L is a manual bone-marrow biopsy and aspiration system for the posterior iliac crest. An outer cannula with a handle surrounds an inner stylet, forming the needle assembly.
A universal Luer-lock connector supports aspiration through the device. Patient-contacting needle material is AISI 304 stainless steel, with different gauges and lengths identifying the available configurations.
Listed Item
Bone Marrow Biopsy and Aspiration System 11G x 15 cm
Size and Supply
MED-L needle cannulas range from 7G to 13G and 100 to 150 mm in length. The system is disposable and supplied sterile after ethylene-oxide sterilization. A listed 11G by 15 cm system is one configuration within this biopsy family.
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) | K192099 |
| Record published | 2020-07-08 |
| Record revised | 2026-07-28 (version 3) |
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 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XL08150-0P | In distribution | |
| XL11150-0P | In distribution | |
| XL08100-0S | In distribution | |
| XL13070-0S | In distribution | |
| XL08100-0P | In distribution | |
| XL13100-0S | In distribution | |
| XL13150-0S | In distribution | |
| XL11100-0P | In distribution | |
| XL08150-0S | In distribution | |
| XL11100-0S | In distribution | |
| XL11150-0S | 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.