Device, Percutaneous, Biopsy

Which Manufacturers in China Make This?

Chinese manufacturers registered for this device type are concentrated in Guangdong, Jiangsu and Shanghai, and 2 other provinces: 5 hold an FDA registration.

Canyon Medical Inc. Jiangsu
Carbon (Shenzhen) Medical Device Co., Ltd. Guangdong
Ningbo Hicren Biotechnology Co., Ltd. Zhejiang
Shanghai KiNETIC Medical Co Ltd Shanghai, contract manufacturer
Tianjin Newtrans Technology Development Tianjin

How Is MJG Classified?

Device, Percutaneous, Biopsy is FDA product code MJG, Class 1, 21 CFR 878.4800.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 4 recalls under this product code since 2010. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Device, Percutaneous, Biopsy

Kyphon® Bone Biopsy Device

Bone Biopsy F18A Bone Biopsy KIT

Device, Percutaneous, Biopsy

Coaxial-Schleuse

413S150162

Device, Percutaneous, Biopsy

Biopsybell SRL

Aghi per biopsia / Biopsy needles

Device, Percutaneous, Biopsy

Vertebroplasty Needles

2 catalogue numbers from 13G & Biopsy needle, listed by Teknimed SAS, France, under Device, Percutaneous, Biopsy. 5 manufacturers in China are registered for this product code.

Device, Percutaneous, Biopsy

Coaxial Airlock

413S150162

Device, Percutaneous, Biopsy

Kyphon V™ Bone Biopsy Device 15ga

VP 15GA Biopsy VPB13 Biopsy /Tamp

Device, Percutaneous, Biopsy

Confidence Spinal Cement System

CONFIDENCE SPINAL CEMENT SYSTEM BIOPSY NEEDLE 13G x 9 Inches

Device, Percutaneous, Biopsy

Biopsy Kit for 8g Vertebroplasty Needle Kit

The biopsy kit for the Synthes Vertecem / Vertecem V + system is a sterile packed kit for taking bone biopsies from the vertebral body.

Device, Percutaneous, Biopsy

Coaxial Sleeve Ø 1,50 (17g)

Coaxial sleeve Ø 1,50 (17G) for PrimoCut Ø 1,20 (18G)x 150,sterile

Device, Percutaneous, Biopsy

Breast Aspiration Dual-Port Biopsy Needle

Dual-port needle with 3-finger control 12cc syringe, 1.5"

Device, Percutaneous, Biopsy

FastCutM

10 CS- Guillotine Needle 14G X 130MM FOR Soft Tissue Biopsy FOR Palium AND Magnum® Bard GUN, With Coaxial

Device, Percutaneous, Biopsy

Echotip

Echotip Disposable Mennuti Sampling Needle Set

Device, Percutaneous, Biopsy

Zavala

Zavala Lung Biopsy Needle

Device, Percutaneous, Biopsy

FastCutE

DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G X 100 mm, COMPATIBLE AUTOMATIC PROMAG 2.2 ® GUN

Device, Percutaneous, Biopsy

Confidence Spinal Cement System

CONFIDENCE SPINAL CEMENT SYSTEM BIOPSY NEEDLE 15G x 9 Inches

Device, Percutaneous, Biopsy

Kyphon Bone Biopsy Kit

Bone Biopsy F18A Kyphx Bone Biopsy KIT

Device, Percutaneous, Biopsy

PaliumNeedle

10CS-DISP.NEEDLE 14GX100mm FOR SOFT TISSUE BIOPSY COMPATIBLE WITH BARD AUTOM. MAGNUM GUN/PALIUM GUN

Device, Percutaneous, Biopsy

EasyLock

DISPOSABLE MENGHINI MODIFIED NEEDLE FOR SOFT TISSUE ASPIRATED BIOPSY 19G X 100 mm

Device, Percutaneous, Biopsy

Biopsy Kit for 10g Vertebroplasty Needle Kit

The biopsy kit for the Synthes Vertecem / Vertecem V + system is a sterile packed kit for taking bone biopsies from the vertebral body.

Device, Percutaneous, Biopsy

Palium Coaxial

GUILLOTINE NEEDLE 12Gx 100 mm FOR SOFT TISSUE FOR PALIUM AND MAGNUM BARD TM WITH COXIAL 11G X 74MM

Device, Percutaneous, Biopsy

Device, Percutaneous, Biopsy

Access KIT 10 Gauge-Diamond TIP/END-Opening-Sterile

Device, Percutaneous, Biopsy

Bone Biopsy Device

Bone Biopsy Device, Square, 9G (3.5mm)

Device, Percutaneous, Biopsy

Symmetry Craig

Symmetry® Trocar, Craig Vertebral Body Biopsy, Calibrated Blunt

Device, Percutaneous, Biopsy

Kyphon V™ Bone Biopsy Device 13ga

VP 13GA Biopsy VPB11 Biopsy /Tamp

Device, Percutaneous, Biopsy

Symmetry Huang

Symmetry® Holder, Huang Vein, Tapering Tip, 1.0 mm Wide Tip, 7 in

Device, Percutaneous, Biopsy

Primocut

PrimoCut 18G (1,2) x 150mm sterile

Device, Percutaneous, Biopsy

Device, Percutaneous, Biopsy

Biopsy Needle KIT 10G

Device, Percutaneous, Biopsy

Greene

Disposable Greene Biopsy Needle Set

Device, Percutaneous, Biopsy

CarbonMed

3 catalogue numbers from VN-T01-1.2(18G)×200, listed by Carbon (Shenzhen) Medical Device Co., Ltd., China, under Device, Percutaneous, Biopsy. 5 manufacturers in China are registered for this product code.

Device, Percutaneous, Biopsy

Franseen

Franseen Lung Biopsy Needle

Device, Percutaneous, Biopsy

Medline Industries, Inc.

Breast Biopsy Tray-LF

Device, Percutaneous, Biopsy

AccuMark

Chiba w/ Accumark

Device, Percutaneous, Biopsy

Palium Needle

DISPOSIBLE NEEDLE FOR SOFT TISSUE BIOPSY 14G x 130 mm COMPATIBLE WITH BARD ® AUTOMATIC MAGNUM ® GUN AND PALIUM GUN

Device, Percutaneous, Biopsy

ACS

CT-US Biopsy Radiology - 205944

Device, Percutaneous, Biopsy

Device, Percutaneous, Biopsy

3 catalogue numbers from ERB7_ERB Biopsy Attachment, listed by GE Healthcare Japan Corporation, Japan, under Device, Percutaneous, Biopsy. 5 manufacturers in China are registered for this product code.

Device, Percutaneous, Biopsy

Kyphon V Premium Vertebroplasty

VP 13GA Biopsy VPB11 Biopsy /Tamp

Device, Percutaneous, Biopsy

FastCutS

DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY 14G x 250 mm COMPATIBLE AUTOMATIC STERYLAB FASTGUN ® GUN

Device, Percutaneous, Biopsy

Intro

10 CS - COAXIAL INTRODUCER NEEDLE 17G X 140mm

Device, Percutaneous, Biopsy

HandCut

10 CS - DISPOSABLE NEEDLE 16G x150mm FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION

Device, Percutaneous, Biopsy

Cook

Coaxial Disposable Franseen Biopsy Needle

Device, Percutaneous, Biopsy

Co-Axial Cannula Bundle

Co-Axial Cannula Bundle 16ga x 16.8cm

Device, Percutaneous, Biopsy

Turner

Turner Biopsy Needle

Device, Percutaneous, Biopsy

Vansonnenberg

Disposable VanSonnenberg One-Step Access Needle Set

Device, Percutaneous, Biopsy

FastCutP

10 CS - DISPOSABLE NEEDLE 18Gx250mm FOR SOFT TISSUE BIOPSY COMPATIBLE AUTOMATIC PROMAG® GUN

Device, Percutaneous, Biopsy

Cardinal Health

Pack Proc Biopsy Soft Tiss IHC

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China

2,581device types they are registered for

340,248device records, each naming its maker

31provinces with a registered manufacturer