Biopsy Needle

Who Makes This Device Type in China?

3 manufacturers in China hold an FDA registration for this device type, based in Jiangsu and Zhejiang.

Micro-Tech (Nanjing) Co., Ltd. Jiangsu, contract manufacturer
Promisemed Hangzhou Meditech Co., Ltd. Zhejiang, contract manufacturer
Suzhou Leapmed Healthcare Corporation Jiangsu, contract manufacturer

How Is FCG Classified?

Biopsy Needle is FDA product code FCG, Class 2, 21 CFR 876.1075.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 4 clearances under this code; the FDA took a median of 273 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 54 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (17), Device Design (11) and Process design (4).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

PAC

Reusable pistol for cytological aspiration

Echotip ClearCore

Echotip ClearCore EUS Biopsy Needle

Single-Use Endfire Biopsy Guide

Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transducer

Oncontrol

2 catalogue numbers from IPN928569, listed by Teleflex Medical LLC, United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Lightning Needle Adapter

Catalogue number LTN01, listed by Arteriocyte Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Precision GI 20GA Motorized EUS Biopsy Device

Precision GI is a motorized fine needle biopsy device used through an ultrasound endoscope. It obtains tissue from submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal…

PrecisionPoint

Transperineal Access System

Single Use Needle Guide

Sterile-packed. Bore diameter 1.6 mm; angle of insertion 0° to the long axis of the transducer

Endodrill Drive System

The EndoDrill Model X drive system supplies rotation to the compatible gastrointestinal biopsy instrument for ultrasound guided tissue sampling. It is used with a flexible ultrasound…

SonoTip II Ebus Flex

SonoTip II EBUS Flex with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Pentax Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8 mm,…

Lightning Needle Set

Catalogue number LTN45, listed by Arteriocyte Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Disposable Brain Biopsy Needle Kit

Catalogue number MDBN-08-28X, listed by AD-Tech Medical Instrument Corp., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Single-Use Dual Biopsy Guide

Sterile packed. Bore diameter 1.6 mm; angle of insertion 0° and 19° to the long axis of the transducer

Sonopsy-C1

1 21G x 100mm biopsy needle with suction syringe 3 Filter paper

EchoTip

Echotip Ultrasound Needle

Paragon

hematobiopsy needle 11 G 15cm

ACS

Amniocentesis Tray

SonoTip II Ebus

SonoTip II EBUS-TBNA Neelde-System for Pentax Endoscope, 22 Gauge needle, round Nitinol stylet, needle ø 0.7 mm, outer ø 1.8 mm

SonoTip® Ebus Pro Flex

SonoTip EBUS Pro with Nitinol Needle, Endobronchial Ultrasound Guided TBNA System for Olympus Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8 mm,…

Acquire™ Pulmonary

Endobronchial Ultrasound Fine Needle Biopsy (FNB) Device

Single-Use Biplane Biopsy Guide

Sterile packed. Bore diameter 2.1 mm; angle of insertion 19° to the long axis of the transducer

Mielo-CAN Iliac

Iliac crest bone-marrow aspiration needle 15G; 6 cm

Biopsy Needle

Endobronchial Ultrasound Flex Tbna Needl

Expect Pulmonary

Endobronchial Ultrasound Transbronchial Aspiration Needle

Mielo-CAN

=Bone marrow biopsy needle, 14G, 40-58 mm; max 78 mm

Mammorep Zeta

Breast localization needle, double hook-wire 20G; 11cm

V. Mueller

V. Mueller FRANKLIN-SILVERMAN BIOPSY NDLE OUTER CANN LGTH 3-3/8 inches 8.6CM CANN HUB LGTH 4-7/8 inches 12.4CM SPLIT NDLE HUB 5-5/8 inches 14.3CM

Mammorep Normal

Breast localization needle, simple hook-wire 21G; 11 cm

Single Use Adaptor Biopsy Valve

MAJ-1414 Single USE Adpater Biopsy Valv

Single-Use Biopsy Guide

Sterile packed. Bore diameter 2.1 mm; angle of insertion 17.7° to the long axis of the transducer

BTT

bone-marrow trasplantation needle 13G 11 cm

NeoNavia Biopsy System

NeoNavia FlexiPulse probe

Endodrill Biopsy Instrument

Sterile single use EndoDrill® GI Biopsy Instrument to be used with EndoDrill® Drive System. The EndoDrill® is a surgical instrument intended to collect tissue for histological examination…

Biopty-CUT

BIOPTY-CUT® Disposable Core Biopsy Needle with Spacer, 14g x 20cm

Biomol

Biomol 20GX200MM

Fast-CUT B

Biopsy needle for automatic gun 18G; 25cm

BNX

Fine Needle Aspiration Needle

Expect Pulmonary Adaptor

Needle Adaptor for use with Expect/Acquire Pulmonary Needle

Single Use Aspiration Needle NA-U200H

The Olympus NA-U200H is a single-use needle for ultrasound-guided fine needle aspiration and biopsy of lesions in or around the gastrointestinal tract. It is used with an Olympus ultrasound…

Single Use Aspiration Needle NA-U201H

The Olympus NA-U201H is a single-use aspiration needle used with an Olympus ultrasound endoscope to sample lesions in or around the gastrointestinal tract. Ultrasound guidance helps…

Harvest Needle

Harvest Needle 13GX100MM

Palium

Automatic Reusable GUN FOR Soft Tissues Biopsy, Palium Type

Vari-Safe

Vari-Safe Injection Needle

EchoTip ProCore

EchoTip Procore, Endobronchial HD Ultrasound Biopsy Needle for Olympus Scopes

EchoTip

EchoTip Ultra, Endobronchial High Definition Ultrasound Needle

Mammorep Loop MLE

Repleaceable device for breast lesions localization 20G; 11 cm

SonoTip® Ebus Pro

SonoTip EBUS Pro with Stainless Steel Needle, Endobronchial Ultrasound Guided TBNA System for Olympus Endoscope, 22 Gauge Needle System, Round Nitinol Stylet, Needle ø 0.7 mm, outer ø 1.8…

VCS

Chorion villi biopsy set; biopsy needle 20G 20 cm

BEN

Bone marrow biopsy needle, Trocar point, 13G x 09cm

X-Screen

Transparent container for transportation of human samples

Beacon

EUS Access System Preloaded 18.5 G Access Needle 0.035 Inch Guidewire Compatible

Trident(TM) Adapt Endoscopic Ultrasound Biopsy Needle(FNB)

Maximum insertion portion diameter:2.5mm,Needle:19G,Maximum needle length:80mm,Needle structure: Butted needle, Working channel: Greater than or equal to 2.8mm,Working Length:1197~1237mm,…

SonoTip Pro Control

SonoTip Pro Control Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheath Diameter 2.7 mm, beveled stylet

Single Use Aspiration Needle NA-U401SX

The ViziShot 2 NA-U401SX is a single use aspiration needle for ultrasound guided sampling of submucosal and extramural lesions in the tracheobronchial tree and gastrointestinal tract. It is…

ClearView

ClearView Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheath Diameter 1.8 mm, beveled stylet

Articulator

The Articulator enteroscope injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.

Spring-CUT

Semiautomatic guillottine type instrum. for soft tissue biopsy 18G; 15cm

Securcut

Securcut 21GX70MM

Extended, Single-Use Biopsy Guide

Sterile-packed. Extended. Bore diameter 1.6mm; angle of insertion 17.7° to the long axis of the transducer

V. Mueller

V. Mueller MENGHINI LIVER BIOPSY SET REPLACEMENT STOPPING PLUG FOR SU21040003, 70MM X 1.4MM

Biopsy Needle

The Carr-Locke injection needle is a single use, disposable, flexible sheath injection needle used for the injection of various types of media through flexible endoscopes.

Bexcore Breast Biopsy Needle

3 catalogue numbers from BXC145, listed by Medicalpark Co., Ltd., South Korea, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Single Use Aspiration Needle NA-220H/230H

8 catalogue numbers from NA-220H-8019, listed by Olympus Medical Systems Corp., Japan, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

ChibaSono

ChibaSono 20G x 220mm US-tip, with graduation and wings

Cook

Liver Access and Biopsy Needle Set

Adjustable Coaxial Temno™ A.C.T.

9 catalogue numbers from 10884450444068, listed by Merit Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Lightning Needle

4 catalogue numbers from LTN105-O, listed by Arteriocyte Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Biopsy Needle

Temno Evolution Needle Biposy 16G X 20CM

Single Use Aspiration Needle

NA-201SX-4022 Single Use Aspiration Needle

Complete-Chiba MR

Chiba type needle with quincke point 20 G; 15 cm

Expect Slimline SL

Catalogue number M00555520, listed by Boston Scientific Corporation, United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

SharkCore

Fine Needle Biopsy Needle

Single Action Biopsy Device

Single Action Biopsy Device 20ga (0.9mm) x 20cm

MReye

MReye, Disposable Chiba Biopsy Needle Inconel

Best-Lisas Dual

Bone marrow biopsy needle 11G x 15cm

Precisa

Precisa 18GX150MM

Quick-Core

Quick-Core, Endoscopic Ultrasound Biopsy Needle

Coaxial Sabd Biopsy Device

13 catalogue numbers from CS-1415-15-T, listed by Argon Medical Devices, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Multicore

Automatic guillotine type instrument for soft tissue biopsy 16G; 15 cm

Best-Lisas

Bone marrow biopsy needle 09G x 15cm

Full-Opty

Semiautomatic soft tissue biopsy device 20G; 15 cm

Trident(TM) Endoscopic Ultrasound Biopsy Needle (FNB)

Sheath: 1.8mm, Needle; 1.1mm, Needle Length out of sheath: 80mm, Material: Co-Cr Alloy, Working channel is more than or equal to 2.8mm, Working Length: 1375~1415mm, EUS FNB needle

Quick-Core

Quick-Core, Biopsy Needle

Temno

Temno Needle Biopsy 20G X 20CM Adjustable Coaxial

Leapmed

Disposable Biopsy Refill Needle, Model: A, 2.1mm(14G)*100mm

Bard®

BARD® Coaxial Biopsy Needle to be used with BARD® MAGNUM® Biopsy Instrument and Biopsy Needles, 13g x 10cm

Truguide

TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop and Additional Blunt Tip Stylet, 19g x 17.8cm

TOP CUT

TOP CUT M 14GX130MM

Somatex

7 catalogue numbers from SOMACORE VERIFY, listed by Biopsybell SRL, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Medline Industries, Inc.

Ultrasound Breast Biopsy Pack

Fast-GUN

Reusable automatic biopsy gun for FAST-CUT needle

Arrow

OnControl® Bone Marrow Biopsy System Comprehensive Tray, 102mm

Interject

Injection Therapy Needle Catheter

Histolock

The Histolock resection kit (5-piece) contains the devices needed for injecting, resecting, and collecting flat lesions. The kit is made up of the Histolock Resection Device, Carr-Locke…

Temno®

37 catalogue numbers from 10884450444167, listed by Merit Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

CorVocet™

34 catalogue numbers from 00884450333341, listed by Merit Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Themy

THEMY AUTOMATIC NEEDLE 18Gx250mm NOTCH 20mm, WITH COAXIAL NEEDLE FOR SOFT TISSUE BIOPSY OF 5 PCS

Gangi-HydroGuard Coaxial Needle

The Gangi-HydroGuard Coaxial Needle provides a pathway for core biopsy instruments in soft tissue. A spring-loaded hollow blunt stylet shields the sharp cannula tip when resistance is low,…

Fast-CUT

Biopsy needle for automatic gun 20G; 15cm

Single-Use Fine Needle Biopsy (FNB) Device

The Olympus NA-U210H SecureFlex is a fine needle biopsy device for sampling lesions within or adjacent to the gastrointestinal tract through an ultrasound endoscope. The assembly includes a…

ATA-CUT

Menghini modified needle for soft tissue biopsy 16G; 9 cm

Gangi-SoftGuard Coaxial Needle

Gangi-SoftGuard and Gangi-HydroGuard are coaxial guiding needles for obtaining soft-tissue core biopsies with separate biopsy instruments. Both are manually operated, sterile, single-use…

SemiCut Coax.

DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 14G X 200 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE LUER, WITH INTRODUCERR

ECO-Chiba

Chiba type needle with quincke point Echonox made 18G; 15 cm

Mammorep Loop MLX

Repleaceable device for breast lesions localization 20G; 11 cm

Temno Evolution®

28 catalogue numbers from 10884450443429, listed by Merit Medical Systems, Inc., United States, under Biopsy Needle. 3 manufacturers in China are registered for this product code.

Complete-Chiba

Chiba type needle with quincke point 20 G; 15 cm

SemiCut

DISPOSABLE SEMIAUTOMATIC GUILLOTINE NEEDLE 18G X 160 mm FOR SOFT TISSUE BIOPSY WITHOUT REMOVABLE LUER

Magnum

MAGNUM® Disposable Core Tissue Biopsy Needle, 20g x 10cm

Chiba Sono

530S070100

ClearTip

ClearTip FNA and FNB Types are intended for ultrasonically guided fine needle aspiration of submucosal and extraluminal lesions of the gastrointestinal tract. The filing describes a…

HS Nota

HS Nota 14GX100MM With Coaxial Introducer

Temno Evolution

Temno Evolution Needle Biposy 20G X 15CM

EasyCut

DISPOSABLE SEMIAUTOMATIC NEEDLE 16G X 100 mm FOR CYTO-HISTOLOGICAL BIOPSY ASPIRATION AS FOR MENGHINI MODIFIED

Biopsybell

Semiautomatic guillotine needle for soft-tissue biopsy

Biopsybell SRL

Needle FOR Bone Marrow Explant

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