Automatic Cutting Needle
18 ga (1.3mm) x 25 cm)
9manufacturers in China registered for this device type
19catalogue numbers in this listing
4510(k) clearances naming this product code
9recalls on this code
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 | Remington Medical, Inc., United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K982401 |
| Record published | 2016-09-21 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Inner carton of 10, shipping carton of 10 |
| Sizes | Needle gauge 14 to 18 G |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NAC-1816 | Needle Gauge 18 G | In distribution |
| NAC-1825MLL | Needle Gauge 18 G | In distribution |
| NAC-1816B | Needle Gauge 18 G | In distribution |
| NAC-1816BB | Needle Gauge 18 G | In distribution |
| NAC-1820 | Needle Gauge 18 G | In distribution |
| NAC-1825U | Needle Gauge 18 G | In distribution |
| NAC-1410MLL | Needle Gauge 14 G | In distribution |
| NAC-1825 ULTRA | Needle Gauge 18 G | In distribution |
| NAC-1825BB | Needle Gauge 18 G | In distribution |
| NAC-1820BB | Needle Gauge 18 G | In distribution |
| NAC-1825M | Needle Gauge 18 G | In distribution |
| NAC-1816M | Needle Gauge 18 G | In distribution |
| NAC-1820MLL | Needle Gauge 18 G | In distribution |
| NAC-1820 ULTRA | Needle Gauge 18 G | In distribution |
| NAC-1825B | Needle Gauge 18 G | In distribution |
| NAC-1820B | Needle Gauge 18 G | In distribution |
| NAC-1820M | Needle Gauge 18 G | In distribution |
| NAC-1410 | Needle Gauge 14 G | In distribution |
| NAC-1820U | Needle Gauge 18 G | 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 |
|---|---|
| K191315 | 2019-07-12 |
| K130282 | 2013-05-13 |
| K040266 | 2004-07-09 |
| K982401 | 1998-09-08 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Remington Medical, Inc. | UDI-DI | 2022-12-02 | Class II | Under Investigation by firm | The stylet is longer than specified on the label | 290 devices | 2026-03-16 |
| Remington Medical, Inc. | 510(k) number | 2012-08-29 | Class II | Material/Component Contamination | Sterility of the product may be compromised. | 800 needles | 2013-01-15 |
| Remington Medical, Inc. | 510(k) number | 2007-01-19 | Not classified | Other | Pouches were not sealed prior to sterilization. | 192 units | 2007-05-11 |
| Remington Medical, Inc. | 510(k) number | 2005-02-15 | Not classified | Other | The stylet hub detaches from the stylet needle. | 1737 units | 2005-05-17 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-02-07 | Not classified | Device Design | There is a potential for the needle hubs to break during use. | 10101 units | 2011-08-12 |
| 2011-02-07 | Not classified | Device Design | There is a potential for the needle hubs to break during use. | 8161 units | 2011-08-12 |
| 2011-02-07 | Not classified | Device Design | There is a potential for the needle hubs to break during use. | 4867 units | 2011-08-12 |
| 2011-02-07 | Not classified | Device Design | There is a potential for the needle hubs to break during use. | 23022 units | 2011-08-12 |
| 2011-02-07 | Not classified | Device Design | There is a potential for the needle hubs to break during use. | 727 units | 2011-08-12 |
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.