EX3 Stepper
For use with Hitachi Aloka Medical C41L47RP and EUP-U533 transducers
44manufacturers in China registered for this device type
4catalogue numbers in this listing
15510(k) clearances naming this product code
28recalls on this code
Who Else Makes It
Concentrated in Guangdong (18), Jiangsu (10), Shanghai (3). 9 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 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| ATL Technology DG,Ltd. | Dongguan | Guangdong | Contract manufacturer | 14 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Hony Medical Co., Ltd. | Taishan | Guangdong | Contract manufacturer | 10 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| 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 |
Showing 12 of 44. All 44 manufacturers in China registered for Transducer, Ultrasonic, Diagnostic
Record
| Listed by | Civco Medical Instruments Co., Inc., United States |
|---|---|
| FDA product code | ITX |
| Device type | Transducer, Ultrasonic, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1570 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K131161 |
| Record published | 2017-08-22 |
| Record revised | 2021-09-06 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Sizes | Width 6.21 in; length 15.97 in; length 44.2 cm; width 20.8 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 644-081 | Width 6.21 in | In distribution |
| 658-007 | In distribution | |
| 642-514 | In distribution | |
| 683-003 | Length 44.2 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 302 |
| Biopsy Starter Kit | Civco Medical Instruments Co., Inc. | 172 |
| Sheathes | Sheathing Technologies, Inc. | 170 |
| Needle Guide | Civco Medical Instruments Co., Inc. | 156 |
| Sheathes3D | Sheathing Technologies, Inc. | 78 |
| Ultrasound Probe Cover Biopsy Needle Guide | Advance Medical Designs, Inc. | 78 |
| ultrasonic transducer | Edan Instruments, Inc. | 70 |
| Unbranded | Advance Medical Designs, Inc. | 68 |
| Reusable Biopsy Bracket | Protek Medical Products, Inc. | 60 |
| Ultrasound Probe Cover Biopsy Needle Guide Kit | Advance Medical Designs, Inc. | 58 |
| Biopsy Bracket | Civco Medical Instruments Co., Inc. | 56 |
| Transducer Cover | Civco Medical Instruments Co., Inc. | 54 |
Showing 12 of 1,678. All products under Transducer, Ultrasonic, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231783 | 2023-11-14 |
| K222052 | 2022-11-22 |
| K211270 | 2021-09-13 |
| K163313 | 2017-06-09 |
| K160806 | 2016-08-05 |
| K131161 | 2013-09-17 |
| K131528 | 2013-06-11 |
| K093713 | 2010-01-19 |
| K013721 | 2001-12-28 |
| K992152 | 1999-08-17 |
| K991236 | 1999-06-02 |
| K970513 | 1997-06-20 |
| K970514 | 1997-06-20 |
| K970515 | 1997-06-20 |
| K843573 | 1984-12-13 |
Recalls Naming This Product
7 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 | 2025-05-01 | Class II | Process design | During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place. | 506 boxes | |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2018-02-23 | Class II | Device Design | A cover failed leak testing during validation testing of new needle guides from a replacement tool. | 177 boxes | 2020-10-06 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 717 boxes | 2017-02-28 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 508 boxes | 2017-02-28 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 1139 boxes | 2017-02-28 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 206 boxes | 2017-02-28 |
| Civco Medical Instruments Co., Inc. | 510(k) number | 2015-10-21 | Class II | Process design | Sterility of the product cannot be assured. | 54 boxes | 2017-02-28 |
Recalls
18 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 |
|---|---|---|---|---|---|
| 2018-11-02 | Class II | Other | 613 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 49 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 66 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 20 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 234 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 115 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. | 948 boxes | 2020-11-20 |
| 2018-11-02 | Class II | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. | 738 boxes | 2020-11-20 |
| 2018-11-02 | Class II | Other | 73 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 257 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 468 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 3 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | 297 boxes | 2020-11-20 | |
| 2018-11-02 | Class II | Other | The needle guide bracket may puncture the sterile cover applied over the transducer and bracket during assembly. | 1,375 boxes | 2020-11-20 |
| 2018-11-02 | Class II | Other | 135 boxes | 2020-11-20 | |
| 2018-07-30 | Class II | Process control | The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. | 3 units | 2020-09-16 |
| 2018-07-30 | Class II | Process control | The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide. | 107 units | 2020-09-16 |
| 2015-02-26 | Class II | Process design | Leaks were detected in the recalled lot which may compromise the sterility of the product. | 120 pouches | 2017-02-28 |
| 2011-01-21 | Not classified | Labeling design | Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information. | 31/24-cover boxes | 2013-07-09 |
| 2010-07-20 | Not classified | Nonconforming Material/Component | Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover. | 22 boxes | 2012-04-13 |
| 2008-01-16 | Not classified | Packaging | Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/034-054) instead of the Shimadzu T/R Needle guide (p/n134-054). | Lot M102250 – 5 boxes; Lot M105440 – 2 boxes | 2008-04-03 |
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.