Protege GPS
70 catalogue numbers from SERB65-08-80-120, listed by Covidien LP, United States, under Stents, Drains And Dilators For The Biliary Ducts. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
70catalogue numbers in this listing
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 | Covidien LP, 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) | K033314 |
| Record published | 2015-10-23 |
| Record revised | 2023-09-18 (version 7) |
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 |
| Storage | Special storage condition: Keep dry |
| Sizes | Length 20 to 80 mm; outer diameter 6 to 14 mm; catheter gauge 6 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SERB65-08-80-120 | Length 80 mm | In distribution |
| SERB65-07-40-80 | Length 40 mm | In distribution |
| SERB65-06-60-80 | Outer Diameter 6 mm | In distribution |
| SERB65-09-60-120 | Length 60 mm | In distribution |
| SERB65-08-80-80 | Length 80 mm | In distribution |
| SERB65-06-20-80 | Length 20 mm | In distribution |
| SERB65-08-40-120 | Outer Diameter 8 mm | In distribution |
| SERB65-07-40-120 | Length 40 mm | In distribution |
| SERB65-12-40-80 | Catheter Gauge 6 Fr | In distribution |
| SERB65-08-60-120 | Length 60 mm | In distribution |
| SERB65-10-20-120 | Outer Diameter 10 mm | In distribution |
| SERB65-14-40-120 | Outer Diameter 14 mm | In distribution |
| SERB65-14-80-80 | Outer Diameter 14 mm | In distribution |
| SERB65-06-20-120 | Outer Diameter 6 mm | In distribution |
| SERB65-08-60-80 | Catheter Gauge 6 Fr | In distribution |
| SERB65-12-80-120 | Length 80 mm | In distribution |
| SERB65-08-30-80 | Outer Diameter 8 mm | In distribution |
| SERB65-07-60-120 | Length 60 mm | In distribution |
| SERB65-12-40-120 | Length 40 mm | In distribution |
| SERB65-10-80-80 | Length 80 mm | In distribution |
| SERB65-06-30-120 | Length 30 mm | In distribution |
| SERB65-12-80-80 | Length 80 mm | In distribution |
| SERB65-06-40-120 | Working Length,120,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,4.5-5.5,Millimeter; | In distribution |
| SERB65-14-30-120 | Outer Diameter 14 mm | In distribution |
| SERB65-10-30-80 | Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,8.5-9.5,Millimeter; | In distribution |
| SERB65-12-20-80 | Length 20 mm | In distribution |
| SERB65-06-80-80 | Catheter Gauge 6 Fr | In distribution |
| SERB65-14-40-80 | Outer Diameter 14 mm | In distribution |
| SERB65-08-20-80 | Length 20 mm | In distribution |
| SERB65-14-20-120 | Length 20 mm | In distribution |
| SERB65-10-60-80 | Length 60 mm | In distribution |
| SERB65-08-40-80 | Working Length,80,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,6.5-7.5,Millimeter; | In distribution |
| SERB65-07-60-80 | Length 60 mm | In distribution |
| SERB65-07-30-80 | Outer Diameter 7 mm | In distribution |
| SERB65-14-80-120 | Length 80 mm | In distribution |
| SERB65-07-80-80 | Outer Diameter 7 mm | In distribution |
| SERB65-12-20-120 | Length 20 mm | In distribution |
| SERB65-09-80-80 | Outer Diameter 9 mm | In distribution |
| SERB65-06-30-80 | Catheter Gauge 6 Fr | In distribution |
| SERB65-06-60-120 | Length 60 mm | In distribution |
| SERB65-09-30-120 | Outer Diameter 9 mm | In distribution |
| SERB65-07-30-120 | Length 30 mm | In distribution |
| SERB65-14-60-80 | Length 60 mm | In distribution |
| SERB65-09-40-80 | Outer Diameter 9 mm | In distribution |
| SERB65-09-20-120 | Outer Diameter 9 mm | In distribution |
| SERB65-09-20-80 | Outer Diameter 9 mm | In distribution |
| SERB65-10-30-120 | Length 30 mm | In distribution |
| SERB65-09-60-80 | Outer Diameter 9 mm | In distribution |
| SERB65-10-40-80 | Length 40 mm | In distribution |
| SERB65-08-30-120 | Length 30 mm | In distribution |
| SERB65-07-20-120 | Outer Diameter 7 mm | In distribution |
| SERB65-14-60-120 | Outer Diameter 14 mm | In distribution |
| SERB65-12-60-80 | Length 60 mm | In distribution |
| SERB65-12-30-120 | Catheter Gauge 6 Fr | In distribution |
| SERB65-10-40-120 | Length 40 mm | In distribution |
| SERB65-09-40-120 | Length 40 mm | In distribution |
| SERB65-10-20-80 | Catheter Gauge 6 Fr | In distribution |
| SERB65-10-60-120 | Length 60 mm | In distribution |
| SERB65-14-20-80 | Length 20 mm | In distribution |
| SERB65-07-20-80 | Outer Diameter 7 mm | In distribution |
| SERB65-14-30-80 | Length 30 mm | In distribution |
| SERB65-06-40-80 | Length 40 mm | In distribution |
| SERB65-06-80-120 | Outer Diameter 6 mm | In distribution |
| SERB65-12-60-120 | Length 60 mm | In distribution |
| SERB65-09-80-120 | Length 80 mm | In distribution |
| SERB65-07-80-120 | Outer Diameter 7 mm | In distribution |
| SERB65-12-30-80 | Length 30 mm | In distribution |
| SERB65-09-30-80 | Length 30 mm | In distribution |
| SERB65-10-80-120 | Working Length,120,Centimeter;Compatible Guidewire,.035,Inch;Lumen Diameter,8.5-9.5,Millimeter; | In distribution |
| SERB65-08-20-120 | Length 20 mm | In distribution |
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
Recalls Naming This Product
12 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| ev3, Inc. | 510(k) number | 2010-10-30 | Not classified | Packaging process control | Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm Protg GPS stent but contains a 14 mm x 6 | 30 | 2012-03-29 |
| ev3, Inc. | 510(k) number | 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 4 | 2011-12-11 |
| ev3, Inc. | 510(k) number | 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 5 | 2011-12-11 |
| ev3, Inc. | 510(k) number | 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 2 | 2011-12-11 |
| ev3, Inc. | 510(k) number | 2009-06-10 | Not classified | Labeling mix-ups | ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected product was labeled as a 6mm x 80mm Prot | 2 | 2011-12-11 |
| ev3, Inc. | 510(k) number | 2006-12-06 | Not classified | Other | Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected. | 2 | 2007-02-03 |
| ev3, Inc. | 510(k) number | 2005-06-10 | Not classified | Other | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. | 1 | 2005-11-17 |
| ev3, Inc. | 510(k) number | 2005-06-10 | Not classified | Other | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. | 1 | 2005-11-17 |
| ev3, Inc. | 510(k) number | 2005-06-10 | Not classified | Other | A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative. | 1 | 2005-11-17 |
| ev3, Inc. | 510(k) number | 2004-09-01 | Not classified | Other | A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is ‘double barrier’ packaged and consists of a sealed inner tray in a sealed pouc | 5 systems | 2005-11-03 |
| ev3, Inc. | 510(k) number | 2004-07-09 | Not classified | Other | Ev3 had received customer complaints indicating that the stent device could not be used with an.035′ guidewire. An investigation found that 6Fr, 135 cm (.018′) stent system were labeled as a 120 cm (.035′) stent system and that 6Fr 120 cm | 10 | 2006-12-28 |
| ev3, Inc. | 510(k) number | 2004-07-09 | Not classified | Other | Ev3 had received customer complaints indicating that the stent device could not be used with an.035′ guidewire. An investigation found that 6Fr, 135 cm (.018′) stent system were labeled as a 120 cm (.035′) stent system and that 6Fr 120 cm | 11 | 2006-12-28 |
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.