Control Syringe
12cc Soft Touch Control Syringe FG/PP/RA w/Reservoir
7manufacturers in China registered for this device type
14catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Beijing (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Argon Medical Devices, Inc., United States |
|---|---|
| FDA product code | IZI |
| Device type | System, X-Ray, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1600 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K911732 |
| Record published | 2016-09-09 |
| Record revised | 2026-05-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 25 |
| Distribution end date | 2025-01-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 193212 | 12cc | In distribution |
| 193222 | 12cc | In distribution |
| 193205 | 10cc | In distribution |
| 193210 | 12cc | In distribution |
| 193248 | 12cc | Withdrawn |
| 193211 | 12cc | Withdrawn |
| 193239 | 12cc | Withdrawn |
| 193206 | 10cc | Withdrawn |
| 193214 | 12cc | Withdrawn |
| 193220 | 10cc | Withdrawn |
| 193249 | 12cc | Withdrawn |
| 193209 | 12cc | Withdrawn |
| 193221 | 12cc | Withdrawn |
| 193203 | 10cc | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterimed | Sterimed, Inc. | 114 |
| Med-Syringe | Argon Medical Devices, Inc. | 16 |
| Novadaq and Pinpoint | Novadaq Technologies, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Namic | Navilyst Medical, Inc. | 9 |
| Namic | Medline Industries, Inc. | 8 |
| iMRX System | Imris Imaging, Inc. | 6 |
| System, X-Ray, Angiographic | B. Braun Medical Inc. | 4 |
| System, X-Ray, Angiographic | Intuitive Surgical, Inc. | 3 |
| Leica FL800 | Leica Microsystems (Schweiz) AG | 3 |
| Infrared 800 with Flow® 800 Option | Carl Zeiss Meditec Inc | 2 |
| Leica FL800 ULT | Leica Microsystems (Schweiz) AG | 2 |
Showing 12 of 51. All products under System, X-Ray, Angiographic
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Argon Medical Devices, Inc. | 510(k) number | 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 1008 syringes | 2007-04-19 |
| Argon Medical Devices, Inc. | 510(k) number | 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 160 kits | 2007-04-19 |
| Argon Medical Devices, Inc. | 510(k) number | 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 203 syringes | 2007-04-19 |
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 |
|---|---|---|---|---|---|
| 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 34 syringes | 2007-04-19 |
| 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 700 syringes | 2007-04-19 |
| 2005-06-27 | Not classified | Other | The firm is recalling the product due to the potential for air aspiration or fluid leakage from a faulty syringe tip. | 2752 syringes | 2007-04-19 |
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.