Biliary Catheter for Stone Removal That May Also Allow for Irrigation and Contrast Injection
24 catalogue numbers from AG-5451-12, listed by Hangzhou AGS MedTech Co., Ltd., China, under Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
24catalogue 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 | Hangzhou AGS MedTech Co., Ltd., China |
|---|---|
| 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 | Repacker / relabeller, Manufacturer |
| 510(k) | K200173 |
| Record published | 2026-07-17 |
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 |
| Packaging | Box of 5, carton of 10, carton of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AG-5451-12 | In distribution | |
| AG-5453-18 | In distribution | |
| AG-5051-2317-12 | In distribution | |
| AG-5053-2317-85 | In distribution | |
| AG-5453-13-15-18 | In distribution | |
| AG-5053-2317-15 | In distribution | |
| AG-5451-10 | In distribution | |
| AG-5053-2317-18 | In distribution | |
| AG-5453-10-12-15 | In distribution | |
| AG-5051-2317-18 | In distribution | |
| AG-5053-2317-13-15-18 | In distribution | |
| AG-5453-15 | In distribution | |
| AG-5451-15 | In distribution | |
| AG-5453-10 | In distribution | |
| AG-5451-10-12-15 | In distribution | |
| AG-5051-2317-13-15-18 | In distribution | |
| AG-5053-2317-12 | In distribution | |
| AG-5051-2317-15 | In distribution | |
| AG-5051-2317-85 | In distribution | |
| AG-5451-18 | In distribution | |
| AG-5451-13-15-18 | In distribution | |
| AG-5051-2317-85-12-15 | In distribution | |
| AG-5053-2317-85-12-15 | In distribution | |
| AG-5453-12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cook | Cook Incorporated | 19 |
| Tri-Ex | Cook Incorporated | 15 |
| 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 |
|---|---|
| K200173 | 2020-05-01 |
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.