Silhouette® Comfort Ureteral Stent
11 catalogue numbers from B3837, listed by Applied Medical Resources Corp., United States, under Stent, Ureteral. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
11catalogue numbers in this listing
5510(k) clearances naming this product code
6recalls 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 | Applied Medical Resources Corp., United States |
|---|---|
| FDA product code | FAD |
| Device type | Stent, Ureteral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.4620 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2015-07-13 |
| Record revised | 2019-01-22 (version 3) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Sizes | Length 10 to 30 cm; catheter gauge 4.6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B3837 | Length 26 cm | In distribution |
| B3832 | Length 16 cm | In distribution |
| B3834 | Length 20 cm | In distribution |
| B3836 | Length 24 cm | In distribution |
| B3833 | Length 18 cm | In distribution |
| B3835 | Length 22 cm | In distribution |
| B3831 | Length 14 cm | In distribution |
| B3830 | Length 12 cm | In distribution |
| B3829 | Length 10 cm | In distribution |
| B3838 | Length 28 cm | In distribution |
| B3839 | Length 30 cm | In distribution |
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 |
| Sof-Flex | Cook Incorporated | 60 |
| Tria™ Firm | Boston Scientific Corporation | 58 |
Showing 12 of 131. All products under Stent, Ureteral
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060673 | 2006-03-29 |
| K040760 | 2004-10-15 |
| K011264 | 2001-07-17 |
| K991219 | 1999-06-21 |
| K930882 | 1993-07-08 |
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 |
|---|---|---|---|---|---|
| 2008-05-20 | Not classified | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. | 30 | 2010-04-14 |
| 2008-05-20 | Not classified | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. | 84 | 2010-04-14 |
| 2008-05-20 | Not classified | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. | 103 | 2010-04-14 |
| 2008-05-20 | Not classified | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. | 4 | 2010-04-14 |
| 2008-05-20 | Not classified | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. | 10 | 2010-04-14 |
| 2008-05-20 | Not classified | Mixed-up of materials/components | The product is being recalled due to possible movement or dislodgement of the positioner marker band during use. | 5 | 2010-04-14 |
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.