Semi Automatic Biopsy Needle

It is a disposable spring loaded biopsy device with a stylet with sample notch and a cm marked echogenic cutting cannula. GEOTEK semiautomatic biopsy needle has two advancement options:…

Registry build 21.09.26

It is a disposable spring loaded biopsy device with a stylet with sample notch and a cm marked echogenic cutting cannula. GEOTEK semiautomatic biopsy needle has two advancement options: 10mm and 20mm

9manufacturers in China registered for this device type
25catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code KNW
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

Regulatory record for Semi automatic Biopsy Needle
Listed by Geotek Medikal VE Saglik Hizmetleri Ticaret Sanayi Limited Sirketi
FDA product code KNW
Device type Instrument, Biopsy
Device class Class 2
Regulation 21 CFR 876.1075
Record published 2023-09-01

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date
Storage Special storage condition: Keep awway from Sun light; Special storage condition: Storage environment temperature between 5-30 degrees celsius

Catalogue Numbers

Catalogue numbers for Semi automatic Biopsy Needle
Catalogue number Size Status
GSN1812 In distribution
GSN1816 In distribution
GSN1825 In distribution
GSN1409 In distribution
GSN1809 In distribution
GSN1415 In distribution
GSN1612 In distribution
GSN2015 In distribution
GSN1410 In distribution
GSN1625 In distribution
GSN2009 In distribution
GSN1810 In distribution
GSN1609 In distribution
GSN2010 In distribution
GSN1610 In distribution
GSN1820 In distribution
GSN1416 In distribution
GSN1615 In distribution
GSN1412 In distribution
GSN1420 In distribution
GSN2016 In distribution
GSN1616 In distribution
GSN2020 In distribution
GSN1815 In distribution
GSN1620 In distribution

Same Product Code

Other products under the same FDA 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

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.

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