Product code GBO
- Device name
- Catheter, Nephrostomy, General & Plastic Surgery
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4200
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041995 | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY | Uresil, LLC | 2004-08-19 |
| K021632 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C | Uresil, L.P. | 2002-06-13 |
| K912109 | URESIL GENERAL PURPOSE DRAINAGE CATHETER | Uresil Corp. | 1991-08-12 |
| K854905 | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | Angiomed U.S., Inc. | 1986-01-24 |
| K854906 | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | Angiomed U.S., Inc. | 1986-01-24 |
| K854907 | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) | Angiomed U.S., Inc. | 1986-01-24 |
| K854909 | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS | Angiomed U.S., Inc. | 1986-01-24 |
| K854911 | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) | Angiomed U.S., Inc. | 1986-01-24 |
| K820867 | PERCUTANEOUS NEPHROSTOMY SET | Van-Tec, Inc. | 1982-04-13 |
| K781664 | SILASTIC NEPHROSTOMY SYSTEM | Dow Corning Corp. Healthcare Industries Materials | 1979-01-22 |
| K781526 | SILASTIC U-TUBE KIT | Dow Corning Corp. Healthcare Industries Materials | 1978-09-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729048565 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729192343 | Flexima™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729192312 | Percuflex Locking Loop | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729192305 | Percuflex Locking Loop | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729192299 | Percuflex Locking Loop | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729192268 | Re-Entry Malecot Nephrostomy Catheter Set | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729124788 | Flexima™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729124771 | Flexima™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729124764 | Flexima™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729079774 | Percuflex Locking Loop | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729079767 | Percuflex Locking Loop | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729077756 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729077749 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729048589 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729048572 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729005209 | TLA Introducer Needle and Sheath | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729048558 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729032076 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729032069 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729032052 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729031178 | VTC™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729012702 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729009757 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729009740 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729009733 | NA | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729008446 | Re-Entry Malecot Nephrostomy Catheter Set | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729005315 | Re-Entry Malecot Nephrostomy Catheter Set | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729005308 | Re-Entry Malecot Nephrostomy Catheter Set | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729005230 | Percuflex Locking Loop | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729005223 | Percuflex Locking Loop | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |