Biopsy Starter Kit
Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 91.5cm) CIV-Flex™ covers (5) for use…
Reusable non-sterile bracket with Infiniti Plus™ (12, 14, 16, 18GA) needle guides (2), Infiniti Plus™ (18, 20, 21/22, 25GA) needle guides (3), (14 x 91.5cm) CIV-Flex™ covers (5) for use with Esaote IOT332 and IOT342 transducers
37manufacturers in China registered for this device type
8catalogue numbers in this listing
7510(k) clearances naming this product code
17recalls on this code
Who Else Makes It
Concentrated in Guangdong (14), Jiangsu (9), Shanghai (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Raise Medical Industries, Inc. | Foshan | Guangdong | Contract manufacturer | 16 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Philips Ultrasound (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Showing 12 of 37. All 37 manufacturers in China registered for System, Imaging, Pulsed Echo, Ultrasonic
Record
| Listed by | Civco Medical Instruments Co., Inc., United States |
|---|---|
| FDA product code | IYO |
| Device type | System, Imaging, Pulsed Echo, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1560 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K092619 |
| Record published | 2017-08-22 |
| Record revised | 2024-02-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Keep Away from Sunlight; Storage environment temperature 52 to 85 °F |
| Sizes | Length 1.97 to 4.04 in; width 1.94 to 2.4 in; height 2.06 to 2.2 in |
| Distribution end date | 2021-02-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 639-051 | Width 1.97 in | In distribution | |
| H4908NB | Height 2.06 in | In distribution | |
| H4908ND | Length 2.4 in | In distribution | |
| H40432LK | Width 2 in | In distribution | |
| 639-052 | Width 1.94 in | In distribution | |
| H40432LF | Width 2.4 in | In distribution | |
| 5304800-2 | Length 4.04 in | 4 | Withdrawn |
| 5364121-2 | Length 4.04 in | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hitachi | Hitachi, Ltd. | 224 |
| eTRAX™ Needle | Civco Medical Instruments Co., Inc. | 43 |
| BladderScan® | Verathon Inc. | 38 |
| Verza Guidance System | Civco Medical Instruments Co., Inc. | 37 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 34 |
| Siui | Shantou Institute OF Ultrasonic Instruments Co., Ltd. | 34 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 33 |
| Tracking Bracket Starter Kit | Civco Medical Instruments Co., Inc. | 29 |
| System, Imaging, Pulsed Echo, Ultrasonic | GE Healthcare Japan Corporation | 23 |
| eTRAX™ Needle System Starter Kit | Civco Medical Instruments Co., Inc. | 20 |
| Tracking Bracket | Civco Medical Instruments Co., Inc. | 19 |
| Logiq | GE Ultrasound Korea, Ltd. | 18 |
Showing 12 of 805. All products under System, Imaging, Pulsed Echo, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K895614 | 1989-12-14 |
| K875236 | 1988-04-15 |
| K875240 | 1988-04-15 |
| K875128 | 1988-04-15 |
| K875241 | 1988-04-14 |
| K844472 | 1985-01-23 |
| K841332 | 1984-05-09 |
Recalls Naming This Product
17 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 |
|---|---|---|---|---|---|---|---|
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 2 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 6 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 18 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 20 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 5 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 5 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 10 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2026-03-02 | Class II | Software change control | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | 21 units | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2021-10-08 | Class II | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | 52 boxes (5 units/box) | 2024-09-30 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2021-10-08 | Class II | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | 9 boxes (5 units/box) | 2024-09-30 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2021-10-08 | Class II | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | 18 boxes (5 units/box) | 2024-09-30 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2021-10-08 | Class II | Device Design | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | 599 boxes (5 units/box) | 2024-09-30 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2012-05-07 | Class II | Component design/selection | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. | 221 kits | 2015-01-07 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2012-05-07 | Class II | Component design/selection | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. | 30 kits | 2015-01-07 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2012-05-07 | Class II | Component design/selection | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. | 100 kits | 2015-01-07 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2012-05-07 | Class II | Component design/selection | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. | 9 kits | 2015-01-07 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2012-05-07 | Class II | Component design/selection | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device. | 24 kits | 2015-01-07 |
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.