UroPass
UroPass Ureteral Access Sheath 11/13 Fr (3.7/4.3 mm) x 24 cm (5/PK)
1manufacturer
15catalogue numbers in this listing
1recall
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
Record
| Listed by | Gyrus Acmi, Inc., United States |
|---|---|
| FDA product code | KNY |
| Device type | Accessories, Catheter, G-U |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K051593 |
| Record published | 2016-10-03 |
| Record revised | 2025-06-02 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 61324BX | In distribution | |
| 61124BX | In distribution | |
| 61224BX | In distribution | |
| 61146BX | In distribution | |
| 61338BX | In distribution | |
| 61238BX | In distribution | |
| 61354BX | In distribution | |
| 61346BX | In distribution | |
| 61154BX | In distribution | |
| 61024BX | In distribution | |
| 61054BX | In distribution | |
| 61246BX | In distribution | |
| 61046BX | In distribution | |
| 61254BX | In distribution | |
| 61138BX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cm | Promepla | 4 |
| Dover | Cardinal Health 200, LLC | 3 |
| Silhouette® Pediatric Ureteral Stent with Urowire® Guidewire | Applied Medical Resources Corp. | 3 |
| UroWire® Guidewire with SL-6® Hydrophilic Coating | Applied Medical Resources Corp. | 2 |
| BI-Flex Access Sheath – 12 inner / 14 outer – Length 45cm | Promepla | 1 |
| Gyrus Acmi, Inc | Gyrus Acmi, Inc. | 1 |
| Acucise® Custom KIT | Applied Medical Resources Corp. | 1 |
| Acucise® Procedural Pack Starter Pack | Applied Medical Resources Corp. | 1 |
| Bard® “C” Clamp | C.R. Bard, Inc. | 1 |
| Acucise® Procedural Pack Universal Pack C | Applied Medical Resources Corp. | 1 |
| Bi-Flex | Promepla | 1 |
| Bard® Drainage Protector and Catheter Plug | C.R. Bard, Inc. | 1 |
Showing 12 of 28. All products under Accessories, Catheter, G-U
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2024-09-11 | Class II | Storage | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures. | 14,093 units |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-19 | Class II | Nonconforming Material/Component | Dilator tips may break in the package and in patients during surgical procedures. | 9520 eaches |
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 |
|---|---|---|---|---|---|
| 2011-04-15 | Not classified | Process control | Gyrus ACMI, Inc. wants to bring a recall issue to their customers attention concerning one lot of their 25BX-PTFE Coated 3 cm Flexible Tip Guidewire. As a result of a manufacturing error in the production this lot of guidewires, some units | 145 | 2012-08-23 |
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.