GBO · Catheter, Nephrostomy, General & Plastic Surgery
General, Plastic Surgery · 21 CFR 878.4200 · Class 1
Overview
| Product Code | GBO |
|---|---|
| Device Name | Catheter, Nephrostomy, General & Plastic Surgery |
| Regulation | 21 CFR 878.4200 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K041995 | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY | Uresil, LLC | Aug 19, 2004 | SESE |
| K021632 | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C | Uresil, L.P. | Jun 13, 2002 | SESE |
| K912109 | URESIL GENERAL PURPOSE DRAINAGE CATHETER | Uresil Corp. | Aug 12, 1991 | SESE |
| K854911 | PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER) | Angiomed U.S., Inc. | Jan 24, 1986 | SESE |
| K854909 | PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS | Angiomed U.S., Inc. | Jan 24, 1986 | SESE |
| K854907 | PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER) | Angiomed U.S., Inc. | Jan 24, 1986 | SESE |
| K854906 | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | Angiomed U.S., Inc. | Jan 24, 1986 | SESE |
| K854905 | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | Angiomed U.S., Inc. | Jan 24, 1986 | SESE |
| K820867 | PERCUTANEOUS NEPHROSTOMY SET | Van-Tec, Inc. | Apr 13, 1982 | SESE |
| K781664 | SILASTIC NEPHROSTOMY SYSTEM | Dow Corning Corp. Healthcare Industries Materials | Jan 22, 1979 | SESE |
| K781526 | SILASTIC U-TUBE KIT | Dow Corning Corp. Healthcare Industries Materials | Sep 20, 1978 | SESE |
Top Applicants
- Angiomed U.S., Inc. — 5 clearances
- Dow Corning Corp. Healthcare Industries Materials — 2 clearances
- Uresil Corp. — 1 clearance
- Uresil, L.P. — 1 clearance
- Uresil, LLC — 1 clearance
