Oncontrol
OnControl (R) Bone Lesion Biopsy System Tray 10ga 15cm / 12ga 19cm (6/BX)
9manufacturers in China registered for this device type
34catalogue 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 |
| Record published | 2024-10-16 |
| Record revised | 2025-12-05 (version 12) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| 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 6, box of 6, case |
| Sizes | Needle gauge 10 to 15 G; length 25 to 197 mm; length 6 to 15 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN928560 | Length 152 mm | In distribution |
| IPN928556 | Length 152 mm | In distribution |
| IPN919013 | In distribution | |
| IPN919011 | In distribution | |
| IPN919031 | Needle Gauge 11 G | In distribution |
| IPN928554 | Needle Gauge 11 G | In distribution |
| IPN919012 | Needle Gauge 11 G | In distribution |
| IPN919014 | Length 102 mm | In distribution |
| IPN928558 | Needle Gauge 11 G | In distribution |
| IPN928555 | Needle Gauge 11 G | In distribution |
| IPN928566 | In distribution | |
| IPN928561 | Needle Gauge 12 G | In distribution |
| IPN919033 | Needle Gauge 11 G | In distribution |
| IPN919021 | Needle Gauge 10 G | In distribution |
| IPN919028 | Length 6 cm | In distribution |
| IPN919023 | Length 15 cm | In distribution |
| IPN919035 | Length 90 mm | In distribution |
| IPN919018 | Length 152 mm | In distribution |
| IPN919032 | Needle Gauge 15 G | In distribution |
| IPN919025 | Needle Gauge 10 G | In distribution |
| IPN919027 | Length 10 cm | In distribution |
| IPN919019 | Needle Gauge 11 G | In distribution |
| IPN919017 | Needle Gauge 15 G | In distribution |
| IPN919029 | Length 6 cm | In distribution |
| IPN928563 | Length 102 mm | In distribution |
| IPN928557 | Length 102 mm | In distribution |
| IPN928553 | Needle Gauge 11 G | In distribution |
| IPN928559 | Needle Gauge 15 G | In distribution |
| IPN928564 | Needle Gauge 10 G | In distribution |
| IPN919016 | Length 152 mm | In distribution |
| IPN928565 | Length 60 mm | In distribution |
| IPN919015 | Length 102 mm | In distribution |
| IPN919034 | Length 102 mm | In distribution |
| IPN928562 | Length 152 mm | 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
5 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. | 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.