Arrow
OnControl® Bone Lesion Biopsy System Tray 10ga 15cm / 12ga 19cm
9manufacturers in China registered for this device type
25catalogue numbers in this listing
5recalls 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | KNW |
| Device type | Instrument, Biopsy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1075 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K113872 |
| Record published | 2016-09-16 |
| Record revised | 2025-07-14 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store between 15 – 30C (59 – 86F). |
| Packaging | Case of 5, carton of 6, carton, case of 6, carton of 10, box of 10 |
| Sizes | Length 60 to 197 mm; needle gauge 10 to 13 G |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN033797 | Length 152 mm | In distribution |
| IPN033799 | In distribution | |
| IPN033803 | Access Needle Length 102mm 10 gauge; Biopsy Needle Length 147mm 12 gauge | In distribution |
| IPN922907 | In distribution | |
| IPN033806 | Access Needle Length 102mm 11 gauge; Biopsy Needle Length 147mm 13 gauge | In distribution |
| IPN033808 | Length 60 mm | In distribution |
| IPN033800 | Length 197 mm | In distribution |
| IPN033811 | In distribution | |
| IPN922906 | In distribution | |
| IPN056179 | In distribution | |
| IPN033741 | In distribution | |
| IPN929523 | In distribution | |
| IPN930098 | In distribution | |
| IPN927015 | In distribution | |
| IPN927014 | In distribution | |
| IPN036849 | In distribution | |
| IPN033807 | In distribution | |
| IPN926862 | In distribution | |
| IPN033836 | In distribution | |
| IPN927016 | In distribution | |
| IPN033802 | In distribution | |
| IPN033810 | In distribution | |
| IPN033796 | In distribution | |
| IPN033805 | In distribution | |
| IPN931356 | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2021-03-08 | Class II | Process design | Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy sample from being collected. Use of a defective device is likely to require immediate repeat biopsy, leading to a prolonged procedure | 3,756 units (US); 249 units (OUS) Expanded 810 units: 774 US | |
| Teleflex Medical LLC | 510(k) number | 2016-11-08 | Class II | Device Design | Sterility: Due to a potential incomplete seal on the outer sterile package. | 2019-11-20 |
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-11-08 | Class II | Device Design | Sterility: Due to a potential incomplete seal on the outer sterile package. | 2019-11-20 | |
| 2016-11-08 | Class II | Device Design | Sterility: Due to a potential incomplete seal on the outer sterile package. | 2019-11-20 | |
| 2016-11-08 | Class II | Device Design | Sterility: Due to a potential incomplete seal on the outer sterile package. | 2019-11-20 | |
| 2016-11-08 | Class II | Device Design | Sterility: Due to a potential incomplete seal on the outer sterile package. | 113,647 units | 2019-11-20 |
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.