Integrated Needle Guide
Sterile needle guide with (17.8 x 147cm) telescopically-folded CIV-Flex™ cover for use with Canon Medical Systems PVI-450BPX (i8CXP1) transducers
37manufacturers in China registered for this device type
2catalogue 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 |
| Record published | 2021-11-20 |
| Record revised | 2024-02-16 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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, manufacturing date |
| Storage | Special storage condition: Keep Away from Sunlight |
| Packaging | Pack of 12, pack of 5 |
| Sizes | Height 1.3 in; length 1.4 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 680-172, 680-172-5 | In distribution | |
| H46332LY, H46332LY-5 | Height 1.3 in | In distribution |
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
17 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 |
|---|---|---|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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.