Tri-Ex
Tri-Ex Extraction Balloon with Multiple Sizing
4manufacturers in China registered for this device type
15catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (3), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Anrei Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 12 |
| Zhejiang Soudon Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 9 |
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | GCA |
| Device type | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K953951 |
| Record published | 2016-09-24 |
| Record revised | 2024-05-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Distribution end date | 2017-09-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G22535 | In distribution | |
| G22532 | In distribution | |
| G22531 | In distribution | |
| G22534 | In distribution | |
| G22533 | In distribution | |
| G26857 | In distribution | |
| G50695 | In distribution | |
| G26856 | In distribution | |
| G22530 | In distribution | |
| G25169 | Withdrawn | |
| G25167 | Withdrawn | |
| G25164 | Withdrawn | |
| G25165 | Withdrawn | |
| G25166 | Withdrawn | |
| G25168 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | Hangzhou AGS MedTech Co., Ltd. | 24 |
| Cook | Cook Incorporated | 19 |
| Silicone T Drainage Tube | Fortune Medical Instrument Corp. | 10 |
| Silicone T Drainage Set With Eyes | Fortune Medical Instrument Corp. | 9 |
| Silicone T Drainage Tube With Eyes | Fortune Medical Instrument Corp. | 8 |
| Ring | Cook Incorporated | 8 |
| Silicone T Drainage Set | Fortune Medical Instrument Corp. | 7 |
| Taxi | Lake Region Medical Limited | 7 |
| Fogarty | Edwards Lifesciences Technology Sarl | 6 |
| Silicone Y Drainage Tube | Fortune Medical Instrument Corp. | 6 |
| Duraglide | ConMed Corporation | 5 |
| Fusion Quattro | Cook Incorporated | 4 |
Showing 12 of 28. All products under Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173414 | 2018-06-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Wilson-Cook Medical Inc. | 510(k) number | 2002-08-28 | Not classified | Other | The product was labeled with a 5 year expiration date instead of a 1 year expiration date. | 2062 units | 2003-11-25 |
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.