Sof-Flex
Sof-Flex is a ureteral stent family that provides temporary internal urinary drainage from the kidney's ureteropelvic junction to the bladder. A single internal lumen maintains a drainage…
Sof-Flex is a ureteral stent family that provides temporary internal urinary drainage from the kidney’s ureteropelvic junction to the bladder. A single internal lumen maintains a drainage path through an obstructed ureter.
The stent is made from radiopaque polyurethane. It is available as a standalone device or in a set with a positioner and wire guide, with different diameters and specified-length or multi-length configurations.
Listed Item
Sof-Flex Large Diameter Double Pigtail Ureteral Stent Set
Placement and Use
Sof-Flex stents can be placed endoscopically, percutaneously or through open surgery. The range spans 3 to 12 Fr in outer diameter and 4 to 32 cm in length; the 3 Fr version is intended for pediatric patients. The devices are supplied sterile for one-time use and are not intended to remain in the body beyond six months.
4manufacturers in China registered for this device type
60catalogue numbers in this listing
13510(k) clearances naming this product code
27recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Shenzhen Trious Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | FAD |
| Device type | Stent, Ureteral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4620 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K180053 |
| Record published | 2015-10-24 |
| Record revised | 2020-05-01 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2018-10-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G14898 | In distribution | |
| G14956 | In distribution | |
| G15939 | In distribution | |
| G16019 | In distribution | |
| G16820 | In distribution | |
| G16821 | In distribution | |
| G15608 | In distribution | |
| G14773 | In distribution | |
| G15898 | In distribution | |
| G15606 | In distribution | |
| G15696 | In distribution | |
| G17676 | In distribution | |
| G27059 | In distribution | |
| G14825 | In distribution | |
| G15607 | In distribution | |
| G17852 | In distribution | |
| G14843 | In distribution | |
| G14943 | In distribution | |
| G14788 | In distribution | |
| G16024 | In distribution | |
| G16881 | In distribution | |
| G14761 | In distribution | |
| G14991 | In distribution | |
| G15076 | In distribution | |
| G14867 | In distribution | |
| G14832 | In distribution | |
| G15929 | In distribution | |
| G14789 | In distribution | |
| G14923 | In distribution | |
| G16040 | In distribution | |
| G15003 | In distribution | |
| G15610 | In distribution | |
| G16880 | In distribution | |
| G14865 | In distribution | |
| G16020 | In distribution | |
| G15150 | In distribution | |
| G15890 | In distribution | |
| G14906 | In distribution | |
| G14854 | In distribution | |
| G16035 | In distribution | |
| G14797 | In distribution | |
| G14790 | In distribution | |
| G15038 | In distribution | |
| G15697 | In distribution | |
| G15624 | In distribution | |
| G14841 | In distribution | |
| G14849 | In distribution | |
| G15397 | In distribution | |
| G14840 | In distribution | |
| G16731 | In distribution | |
| G14866 | In distribution | |
| G15077 | In distribution | |
| G15138 | In distribution | |
| G14951 | In distribution | |
| G15093 | In distribution | |
| G15000 | In distribution | |
| G16021 | In distribution | |
| G14783 | In distribution | |
| G17793 | Withdrawn | |
| G14830 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Porges Coloplast | Coloplast A/S | 509 |
| Polaris™ Ultra | Boston Scientific Corporation | 406 |
| Universa | Cook Incorporated | 384 |
| Percuflex™ Plus | Boston Scientific Corporation | 300 |
| Polaris™ Loop | Boston Scientific Corporation | 232 |
| ImaJin | Coloplast A/S | 219 |
| Contour™ | Boston Scientific Corporation | 205 |
| Percuflex™ | Boston Scientific Corporation | 152 |
| Tecoflex | Gyrus Acmi, Inc. | 92 |
| Vortek | Coloplast A/S | 92 |
| Tria™ Firm | Boston Scientific Corporation | 58 |
| Q Urological Persistent Aguamedicina | Q Urological Corporation | 44 |
Showing 12 of 131. All products under Stent, Ureteral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K181971 | 2019-04-23 |
| K180557 | 2018-11-23 |
| K180216 | 2018-09-28 |
| K180029 | 2018-09-21 |
| K180053 | 2018-09-13 |
| K171603 | 2018-04-16 |
| K172017 | 2018-03-26 |
| K170010 | 2017-08-28 |
| K162109 | 2017-06-07 |
| K162104 | 2017-04-24 |
| K161236 | 2017-01-27 |
| K160891 | 2016-06-24 |
| K151051 | 2016-01-11 |
Recalls
8 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 |
|---|---|---|---|---|---|
| 2021-01-04 | Class II | Nonconforming Material/Component | Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation. | 42 units | 2021-09-16 |
| 2020-07-30 | Class II | Under Investigation by firm | Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product. | 20 units | 2021-11-04 |
| 2019-01-04 | Class II | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. | 13388 total | 2020-05-29 |
| 2019-01-04 | Class II | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. | 13388 total | 2020-05-29 |
| 2019-01-04 | Class II | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. | 13388 total | 2020-05-29 |
| 2019-01-04 | Class II | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. | 13388 total | 2020-05-29 |
| 2019-01-04 | Class II | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. | 13388 total | 2020-05-29 |
| 2019-01-04 | Class II | Process control | The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip. | 13388 total | 2020-05-29 |
| 2010-10-18 | Not classified | Packaging | The firm received a customer complaint that a box labeled as Universa Firm Stents but the box actually contained Universa Soft Stents. The inner product label is correct but the outer box is wrong. | 25 units | 2011-07-27 |
| 2008-11-10 | Not classified | Labeling mix-ups | “Soft” stents were placed in “firm” stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the pa | 23 | 2009-11-25 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2008-07-31 | Not classified | Process control | The bond may break where the two materials meet, resulting in separation of the stent. | 1739 of all products. | 2009-11-27 |
| 2007-06-29 | Not classified | Other | The radiographic band may detach from the stent and remain in the patient after removal of the stent. | 75 | 2008-06-11 |
| 2006-03-01 | Not classified | Other | Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, cont | 1300 | 2008-07-01 |
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.