Home › Device types › GBO
Catheter, Nephrostomy, General & Plastic Surgery
FDA product code GBO · Class 1 · General, Plastic Surgery
413
Registered devices
1,835
Adverse events
8
Recalls
11
510(k) clearances
Devices with this code
SKATER™ All Purpose and Nephrostomy Drainage Set — ARGON MEDICAL DEVICES, INC.ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INCSKATER™ All-Purpose and Nephrostomy Drainage Set — ARGON MEDICAL DEVICES, INC.Total Abscession — Angiodynamics, Inc.Skater™ All Purpose and Nephrostomy Drainage Set — ARGON MEDICAL DEVICES, INC.GP General Purpose Drainage Catheter — URESIL, LLCSKATER™ All-Purpose and Nephrostomy Drainage Set — ARGON MEDICAL DEVICES, INC.Skater™ Nephrostomy Catheter — ARGON MEDICAL DEVICES, INC.SKATER™ All-Purpose and Nephrostomy Drainage Set — ARGON MEDICAL DEVICES, INC.Skater™ Nephrostomy Catheter — ARGON MEDICAL DEVICES, INC.ACCEL® — B BRAUN INTERVENTIONAL SYSTEMS, INCNephro-Cath Nephrostomy Drainage Catheter — URESIL, LLCAmplatz — COOK INCORPORATEDNephro-Cath Nephrostomy Drainage Catheter — URESIL, LLCSKATER™ All-Purpose and Nephrostomy Drainage Set — ARGON MEDICAL DEVICES, INC.GP General Purpose Drainage Catheter — URESIL, LLCNephro-Cath Nephrostomy Drainage Catheter — URESIL, LLCFlexima™ — BOSTON SCIENTIFIC CORPORATIONGP General Purpose Drainage Catheter — URESIL, LLCGP General Purpose Drainage Catheter — URESIL, LLCNephro-Cath Nephrostomy Drainage Catheter — URESIL, LLCNephro-Cath Nephrostomy Drainage Catheter — URESIL, LLCGP General Purpose Drainage Catheter — URESIL, LLCGP General Purpose Drainage Catheter — URESIL, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-12-27 | Cook Inc. | Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2017-12-12 | Boston Scientific Corporation | Certain Malecot Nephrostomy Catheters are breaking at the mid-shaft bond during use. |
| 2009-03-18 | Boston Scientific Corporation | Boston Scientific Corporation is initiating an urgent Field Correction related to its Flexima and Percuflex Drainage Catheter Family (Pigtail Style). During t |
| 2004-06-25 | Boston Scientific Corp | Mislabeled as to size; 10FR are labeled as 8FR. |
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