Bard® InLay Optima® Ureteral Stent
Inlay Optima Ureteral Stent W/O Guidewire
4manufacturers in China registered for this device type
28catalogue numbers in this listing
7510(k) clearances naming this product code
8recalls 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 | C.R. Bard, Inc., 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2015-05-29 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter gauge 4.7 to 8 Fr; length 14 to 30 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 788626 | Catheter Gauge 6 Fr | In distribution |
| 788720 | Catheter Gauge 7 Fr | In distribution |
| 788722 | Catheter Gauge 7 Fr | In distribution |
| 788620 | Catheter Gauge 6 Fr | In distribution |
| 788724 | Length 24 cm | In distribution |
| 788828 | Catheter Gauge 8 Fr | In distribution |
| 788420 | Catheter Gauge 4.7 Fr | In distribution |
| 788630 | Catheter Gauge 6 Fr | In distribution |
| 788428 | Catheter Gauge 4.7 Fr | In distribution |
| 788728 | Catheter Gauge 7 Fr | In distribution |
| 788822 | Catheter Gauge 8 Fr | In distribution |
| 788814 | Length 14 cm | In distribution |
| 788820 | Catheter Gauge 8 Fr | In distribution |
| 788628 | Length 28 cm | In distribution |
| 788714 | Length 14 cm | In distribution |
| 788830 | Catheter Gauge 8 Fr | In distribution |
| 788622 | Length 22 cm | In distribution |
| 788426 | Catheter Gauge 4.7 Fr | In distribution |
| 788624 | Catheter Gauge 6 Fr | In distribution |
| 788824 | Length 24 cm | In distribution |
| 788730 | Length 30 cm | In distribution |
| 788422 | Catheter Gauge 4.7 Fr | In distribution |
| 788826 | Catheter Gauge 8 Fr | In distribution |
| 788424 | Length 24 cm | In distribution |
| 788614 | Catheter Gauge 6 Fr | In distribution |
| 788726 | Catheter Gauge 7 Fr | In distribution |
| 788430 | Catheter Gauge 4.7 Fr | In distribution |
| 788414 | Length 14 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 |
|---|---|
| K043193 | 2004-12-07 |
| K022447 | 2003-01-23 |
| K983498 | 1998-12-15 |
| K903345 | 1991-04-30 |
| K883561 | 1988-11-15 |
| K861478 | 1986-05-15 |
| K823487 | 1983-05-27 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| C.R. Bard, Inc. | UDI-DI | 2025-11-06 | Class II | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 4350 units |
| C.R. Bard, Inc. | UDI-DI | 2025-11-06 | Class II | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 116 units |
| C.R. Bard, Inc. | UDI-DI | 2025-11-06 | Class II | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 116 units |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2025-11-06 | Class II | Under Investigation by firm | Labeling discrepancy; Ureteral stent actual size may not match the actual product label. | 116 units | |
| 2016-10-13 | Class II | Labeling Change Control | Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. | 75,089 units | 2022-02-10 |
| 2016-10-13 | Class II | Labeling Change Control | Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. | 75,089 units | 2022-02-10 |
| 2016-10-13 | Class II | Labeling Change Control | Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. | 75,089 units | 2022-02-10 |
| 2016-10-13 | Class II | Labeling Change Control | Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal. | 75,089 units | 2022-02-10 |
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.