Exodus
10F x 25cm Standard Loop Nephrostomy Drainage Catheter with GLYCE Hydrophilic Coating
6manufacturers in China registered for this device type
43catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| Dongguan TT Medical, Inc. | Dongguan | Guangdong | Manufacturer | 4 |
| LEO Medical Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Navilyst Medical, Inc., United States |
|---|---|
| FDA product code | FGE |
| Device type | Stents, Drains And Dilators For The Biliary Ducts |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5010 |
| 510(k) | K152069 |
| Record published | 2016-08-05 |
| Record revised | 2022-03-08 (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 | Box of 5 |
| Sizes | Catheter gauge 6 to 14 Fr; outer diameter 2.1 to 4.7 mm; length 15 to 35 cm |
| Distribution end date | 2021-08-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10532 | Catheter Gauge 12 Fr | In distribution |
| 10512 | Outer Diameter 3.4 mm | In distribution |
| 10528 | Catheter Gauge 14 Fr | In distribution |
| 10529 | Outer Diameter 4 mm | In distribution |
| 10151 | Outer Diameter 3.4 mm | In distribution |
| 10427 | Catheter Gauge 14 Fr | In distribution |
| 10521 | Length 35 cm | In distribution |
| 10411 | Length 25 cm | In distribution |
| 10423 | Length 25 cm | In distribution |
| 10580 | Catheter Gauge 8 Fr | In distribution |
| 10428 | Outer Diameter 4.7 mm | In distribution |
| 10531 | Catheter Gauge 10 Fr | In distribution |
| 10522 | Catheter Gauge 12 Fr | In distribution |
| 10434 | Catheter Gauge 12 Fr | In distribution |
| 10424 | Outer Diameter 4 mm | In distribution |
| 10527 | Outer Diameter 4 mm | In distribution |
| 10044 | Length 35 cm | In distribution |
| 10510 | Outer Diameter 2.1 mm | In distribution |
| 10526 | Outer Diameter 3.4 mm | In distribution |
| 10524 | Catheter Gauge 14 Fr | In distribution |
| 10530 | Length 25 cm | In distribution |
| 10540 | Outer Diameter 2.7 mm | In distribution |
| 10580 | Length 35 cm | In distribution |
| 10550 | Catheter Gauge 8 Fr | In distribution |
| 10412 | Length 25 cm | In distribution |
| 10525 | Outer Diameter 2.7 mm | In distribution |
| 10143 | Catheter Gauge 8 Fr | In distribution |
| 10052 | Length 35 cm | In distribution |
| 10541 | Outer Diameter 3.4 mm | In distribution |
| 10516 | Catheter Gauge 8 Fr | In distribution |
| 10572 | Length 35 cm | In distribution |
| 10590 | Length 35 cm | In distribution |
| 10407 | Catheter Gauge 8 Fr | In distribution |
| 10436 | Outer Diameter 4.7 mm | In distribution |
| 10520 | Outer Diameter 2.1 mm | In distribution |
| 10518 | Length 25 cm | In distribution |
| 10403 | Outer Diameter 2.7 mm | In distribution |
| 10562 | Outer Diameter 4.7 mm | In distribution |
| 10571 | Outer Diameter 3.4 mm | In distribution |
| 10514 | Catheter Gauge 6 Fr | In distribution |
| 10415 | Outer Diameter 3.4 mm | Withdrawn |
| 10002 | Catheter Gauge 8 Fr | Withdrawn |
| 10404 | Catheter Gauge 8 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Zimmon | Cook Ireland Ltd | 213 |
| Single Use Biliary Drainage Stent V | Olympus Medical Systems Corp. | 181 |
| Mustang™ | Boston Scientific Corporation | 167 |
| Geenen | Cook Ireland Ltd | 158 |
| Cotton-Leung | Cook Ireland Ltd | 144 |
| Advanix™ Pancreatic Stent | Boston Scientific Corporation | 135 |
| Single Use Biliary Stent V | Olympus Medical Systems Corp. | 106 |
| Single-use Balloon Dilatation Catheter | LEO Medical Co., Ltd. | 102 |
| Biliary Plastic Stent Set | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| Biliary Plastic Stent | Micro-Tech (Nanjing) Co., Ltd. | 90 |
| M-Drain | Mermaid Medical A/S | 86 |
| Advanix™ Biliary | Boston Scientific Corporation | 84 |
Showing 12 of 212. All products under Stents, Drains And Dilators For The Biliary Ducts
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152069 | 2015-09-24 |
| K111315 | 2011-06-08 |
| K103353 | 2011-01-14 |
| K093392 | 2009-12-31 |
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.