Acucise® Procedural Pack
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX B3305, STENT, C-FLEX 7/10F x 22 CM
4manufacturers in China registered for this device type
1catalogue number
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 | 2015-10-09 |
| Record revised | 2024-12-23 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2018-10-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BK022 | Withdrawn |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 |
| 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.