RX Locking Device and Biopsy Cap
Locking Device and Biopsy Cap For Use with RX Biliary System
21manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (7), Shanghai (5). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Smartdata Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 11 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Jiana Sterilization Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 23 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
Showing 12 of 21. All 21 manufacturers in China registered for Endoscope Channel Accessory
Record
| Listed by | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | ODC |
| Device type | Endoscope Channel Accessory |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2024-07-25 (version 5) |
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 |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M00545270 | In distribution | |
| M00545260 | In distribution | |
| M00545280 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CeroFrict | SML MED-Tech Solutions Limited | 60 |
| Disposable Endoscopy Adapter Sets | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 14 |
| andorate® Biopsy Valve | GA Health Company Limited | 8 |
| andorate® 4-piece Valve Kit | GA Health Company Limited | 8 |
| Cook | Cook Incorporated | 7 |
| Water Jet Adapter | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | 7 |
| andorate® 3-piece Valve Kit | GA Health Company Limited | 7 |
| Air Water Channel Cleaning Adapter + Champion 3-piece Valve Kit | GA Health Company Limited | 7 |
| Defendo Single Use Valve Kit | Medivators Inc | 6 |
| Disposable Endoscope Valves Kit | Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory) | 6 |
| Andorate | Smartdata Suzhou Co., Ltd. | 6 |
| BullDog® | Diversatek Healthcare Inc | 6 |
Showing 12 of 89. All products under Endoscope Channel Accessory
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252910 | 2025-10-09 |
| K210353 | 2021-05-06 |
| K010610 | 2001-03-27 |
Recalls
1 of these is 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 |
|---|---|---|---|---|
| 2026-05-12 | Class II | Process control | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking. | 9750 units |
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.