Catheter, Nephrostomy, General & Plastic Surgery
FDA product code GBO · Class I (low risk) · 21 CFR 878.4200 · General, Plastic Surgery
11510(k) clearances
0PMA approvals
7recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K041995 | Modification to: GP General Purpose Drainage Catheter, Mini-Pig Drainage Catheter…GBO · Special | Uresil, LLC | 08/19/2004SE |
| K021632 | GP General Purpose Drainage Catheter; Mini-Pigtail Drainage Catheter with Locking…GBO · Special | Uresil, L.P. | 06/13/2002SE |
| K912109 | Uresil General Purpose Drainage CatheterGBO · Traditional | Uresil Corp. | 08/12/1991SE |
| K854911 | Percutaneous Nephrostomy Sets (Schuller)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854909 | Pediatric Percutaneous Nephrostomy SetsGBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854907 | Percutaneous Nephrostomy Sets (Gunther)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854906 | Percutaneous Nephrostomy Sets (Otto)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K854905 | Percutaneous Nephrostomy Sets (Loop Technique)GBO · Traditional | Angiomed U.S., Inc. | 01/24/1986SE |
| K820867 | Percutaneous Nephrostomy SetGBO · Traditional | Van-Tec, Inc. | 04/13/1982SE |
| K781664 | Silastic Nephrostomy SystemGBO · Traditional | Dow Corning Corp. Healthcare Industries Materials | 01/22/1979SE |
| K781526 | Silastic U-Tube KitGBO · Traditional | Dow Corning Corp. Healthcare Industries Materials | 09/20/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0815-2020 Class II | Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL…Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could… | Cook Inc. | 12/27/2019Terminated |
| Z-1104-2018 Class II | Percutaneous Access Set, Product Number: M0064201150, GTIN: 08714729009757 The Malecot…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | Boston Scientific Corporation | 12/12/2017Terminated |
| Z-1103-2018 Class II | Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101050, GTIN:…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | Boston Scientific Corporation | 12/12/2017Terminated |
| Z-1102-2018 Class II | Re-Entry" Malecot Nephrostomy Catheter Set, Product Number: M0064101040, GTIN:…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | Boston Scientific Corporation | 12/12/2017Terminated |
| Z-1101-2018 Class II | Malecot Nephrostomy Catheter Set, Product Number: M0064101010, GTIN: 08714729005278 The…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | Boston Scientific Corporation | 12/12/2017Terminated |
| Z-1100-2018 Class II | Malecot Nephrostomy Catheter Set, Product Number: M0064101000, GTIN: 08714729005261 The…Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. | Boston Scientific Corporation | 12/12/2017Terminated |
| Z-1339-2009 | Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN#…Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex… | Boston Scientific Corporation | 03/18/2009Terminated |